Summary of Classification and Definition Results of Medical


On February 18, 2019, the Central People's Procuratorate issued " Summary of Classification and Definition Results of Medical Device Products in 2018", involving 573 products divided into seven categories:
I. Products under Class III Medical Device Management (69);
II. Products managed according to Class II medical devices (122);
Three, according to the class I medical device management products (219);
Four, not only as a medical device management products (19);
Five, according to the combination of drugs and equipment management products (22);
Six, not as a medical device management products (110);
Seven, depending on the specific circumstances of the product (12).
The full text is as follows:
Notes: 1. The product classification definition results are based on the information provided by the applicant, and do not represent the recognition of the safety and effectiveness of its products, but only serve as a reference for the registration and filing of medical device products;The product description and expected use in the results are used to determine the management attributes and categories of products, and do not represent the complete expression of the registration or filing contents of related products.
2. There is currently no " classification code" corresponding to the first-level product category in the Medical Device Classification Catalogue, which is indicated by " 00". For example, the classification code of " Plasma Therapeutic Apparatus" is 09-00.
I. Products Managed by Class III Medical Devices (69)
1. Hard corneal contact lens care solution: consists of disodium ethylenediamine tetraacetate, benzyl alcohol, polyethylene glycol octylphenyl ether, sodium dodecyl ether sulfate and distilled water.Used for cleaning and disinfection of hard corneal contact lens.After cleaning and disinfection, contact lenses must be thoroughly rinsed with clear water or normal saline before wearing.Classification code: 16-06.
2. Medium-term preservation solution of isolated cornea: composed of DMEM culture medium, chondroitin sulfate, low molecular dextran, dexamethasone, tobramycin, HEPES and water for injection.It is used for storage and transportation of isolated corneas donated by donors.When in use, the isolated cornea donated by the donor is soaked in the preservation solution, and the activity of corneal endothelial cells and corneal limbal epithelial cells can be maintained through nutrients contained in the preservation solution, thereby prolonging the preservation time of the cornea.Classification code: 02-15.
3. Retinal phototherapy instrument: It consists of a wearing outer cover, a host computer, a data management system and accessories (power adapter and data cable).The therapeutic apparatus uses LED continuous light source with specific wavelength and brightness, and patients wear the therapeutic apparatus to irradiate fundus during sleep.The dark adaptation process of cylindrical cells is weakened by illumination method, and excessive growth of vascular endothelial growth factor is inhibited, so as to relieve diabetic retinopathy.It cannot be used for diabetic patients with ulcer wound and acute inflammation of eyes, diabetic patients with incomplete eyelid closure (rabbit eyes), juvenile diabetic patients, and diabetic patients with insomnia.Classification code: 16-05.
4. Implantable biliary drainage tube: composed of biliary drainage tube with locking pigtail structure (including hydrophilic coating), metal reinforced sleeve, bendable hardened sleeve, reducer and tail cap.The hydrophilic coating consists of polyvinylpyrrolidone, polyacrylamide, isopropanol (15%) and water.Made of metal and polymer materials.Aseptic, disposable.Percutaneous implantation into biliary tract.It is used to drain bile into digestive tract or outside body in biliary tract system.The indwelling time in the body is more than 30 days (not more than 90 days).The components contained in the coating have no pharmacological effect.Classification code: 14-05.
5. Vascular lumen intervention can regulate and control the membrane rupture system, which consists of a positioning bracket, a membrane rupture needle and a conveyor.Aseptic, disposable.When in use, the radial artery or carotid artery intervention is preset to the aortic arch of the branch vessel to be reconstructed.Used for in-situ fenestration and reconstruction of superior branch artery of aortic arch during aortic endovascular repair.Classification code: 03-13.
6. Implanted Tantalum Suture for Bone Joint: Consists of Tantalum Wire and Medical Suture Needle.It is used to pull, bind and fabricate bridge-like traction structures for sculpted costal cartilage during ear reconstruction surgery.It will not be taken out after implantation.Classification code: 13-01.
7. Titanium wire for bone joint (with needle): It consists of titanium wire and medical stainless steel suture needle.It is used for non-soft tissue suture or binding fixation such as sternal closure during surgery.It will not be taken out after implantation.Classification code: 13-01.
8. Zirconia slurry for manufacturing all-ceramic denture by adding materials: composed of zirconia, hafnium oxide, yttrium oxide and other oxides.The technology of adding materials is used to make crowns, bridges, inlays and veneers of zirconia all-ceramic denture.Classification code: 17-06.
9. Special sterile injection kit (used in combination with triptorelin acetate for drug injection and pamoate for injection): syringe and injection needle, which are placed in a sterile package, and related drugs (triptorelin acetate for injection and pamoate for injection) are placed in another large package for injecting the drugs in the large package into patients.Classification code: 14-01.
10. Non-absorbable sutures containing silicon/salt layer: composed of inner braided sheath, outer braided sheath, medical grade silicon/salt layer and medical grade silica gel layer from outside to inside.The outer braided sheath is made of ultra-high molecular weight polyethylene (UHMWPE), polyester (PET) (nylon or not) and coloring material.The inner braided sheath is made of polyester (PET) material.The medical grade silicon/salt layer consists of silicone/sodium chloride.The medical grade silica gel layer is made of silicone.Aseptic, disposable.It is used for suturing soft tissues, organs, skin and allogenic soft tissues in orthopedic surgery and/or ligation.The tissue can be pulled to a desired position by passing the suture through soft tissue and tightening the suture, and the fixed suture maintains a fixing force or a ligating force.The salt/silicon layer of the product can absorb the liquid to expand gradually after contacting with water at the seam;This radial expansion of the core leads to a slight shortening of suture length, reducing slack and gaps at the suture to increase the fixation force on the tissue.Classification code: 02-13.
11. Oxygen pressure chamber: composed of main engine and chamber body.The main engine provides cabin pressure and high concentration oxygen, and controls temperature and humidity.The cabin provides the environment needed for patient treatment.After the patient enters the cabin and is sealed, the patient inhales air rich in high-concentration oxygen through the nose.It can be used for adjuvant physical therapy of hyperlipidemia, hypertension, hyperglycemia, cardiovascular and cerebrovascular diseases, etc., and can inhibit tumor cells and improve the effect of radiotherapy and chemotherapy.Classification code: 09-08.
12. Plasma therapeutic instrument: mainly composed of main machine and hand-held end (or therapeutic head), which can contain helium bottle and does not contain helium.Low temperature atmospheric pressure plasma is generated by applying high frequency and high voltage to helium gas.During treatment, a user holds the hand-held end of the instrument to enable plasma jet to irradiate the wound surface.It can be used for adjuvant treatment of neurodermatitis, acne, foot wound healing of type II diabetes, and wound sterilization of human body.Classification code: 09-00.
13. Drug screening analysis software: software products.By analyzing the pharmacogenomics data of the patient, medication evaluation information (dose reduction/increase, drug replacement or normal medication) matching the genotype of the subject is obtained.Classification code: 21-04.
14. Medical endoscope planer: mainly composed of main machine, software, hand tools, cutting tools, foot switch and liquid collecting bottle.In minimally invasive endoscopic surgery (e.g. laryngoscope, cystoscope, hysteroscope, rectoscope, amniotic fluid mirror, etc.), it is used for crushing, planing and cutting human tissue, sucking out the tissue and collecting it in a liquid collecting bottle.Classification code: 01-09.
15. Medical X-ray skin quantitative therapeutic instrument: it consists of control software, source storage box, upright post and base.The software can automatically calculate the treatment duration according to the prescription dose issued by the doctor, so as to calculate and control the dose of nuclides required for skin treatment, and has a timing warning function.No radioactive sources.Classification code: 05-02.
16. Breast biopsy sample rotary cutting system: mainly composed of main machine, foot switch, vacuum pipeline, guiding device and disposable rotary cutting probe.Under the guidance of ultrasound, stereo positioning or nuclear magnetic resonance images, breast tissue samples are peeled off through a rotary cutting probe on a handle, and the samples are sucked into a collection container through vacuum suction, and biopsy results are used for diagnosis of breast diseases.Classification code: 06-10.
17. Phlegm discharge system: it consists of main machine, sampling tube assembly and consumables (including tee joint, sputum collection connector and sputum collection cup).And is connected with a ventilator pipeline; after the ventilator used by the patient supplies a complete inhalation, exhaust air flow is generated, sputum in the bronchiole is sucked to the main bronchus and then discharged from the artificial airway, and is collected into a sputum collecting cup of a sputum discharging system.This product is directly connected with a variety of ventilators and works with ventilator pipelines.Classification code: 09-04.
18. Lung nodule auxiliary diagnosis software: software products.It mainly consists of a patient medical information data module, an image browsing module and a clinical diagnosis analysis module.Used to identify pulmonary nodules (especially small pulmonary nodules);The qualitative conclusion of CT signs of pulmonary nodules is given, and quantitative information such as diameter, volume and CT value of pulmonary nodules are calculated.To predict the malignant risk of nodules.Classification code: 21-04.
19. Breast cancer auxiliary diagnosis software: mainly composed of patient medical information data module, image browsing module and clinical diagnosis analysis module.Used to identify breast lumps;The qualitative conclusion of breast mass is given, and quantitative information such as its diameter, area and distance from nipple are calculated.To predict the malignant risk of breast masses.Classification code: 21-04.
20. Head stereotaxic instrument: mainly composed of fixed head frame, air bag, inflation device, vernier caliper and marker pen.After wearing the product, adjust the CT scanning baseline to coincide with the plane formed by the three-dimensional frame inside the product, and perform CT scanning.After scanning, the largest focus plane and the focus target center are selected according to the CT image, the mark position of the focus on the skull surface is determined, and the mark pen is used for marking.Used to fix the head and provide extracranial auxiliary marks of intracranial lesions for intracranial operations such as intracranial qualitative biopsy, brain tumor radiation, local drug therapy, deep brain electrode implantation, etc.Classification code: 01-07.
21. Microcurrent stimulator: It consists of host computer, system software, electrodes and headband.When in use, the patient wears a headband, and the electrodes generate current to stimulate the head.Can be used for adjuvant treatment of insomnia caused by anxiety and depression.Classification code: 09-01.
22. Anti-fogging liquid for endoscope: the main component is surfactant and does not contain drug components.During otolaryngology, oral cavity, digestive tract, anorectal and other surgical operations, it is smeared on the surface of the endoscope to prevent the surface of the endoscope from fogging due to the temperature difference with the human body.Classification code: 06-16.
23. Near-infrared brain hematoma detector: mainly composed of hand-held scanner, disposable protective cover and communication base.The instrument uses infrared technology to detect traumatic hematomas. By comparing the absorption of near infrared light on the left and right sides of the brain, it can be used as an auxiliary method for clinical evaluation of suspected traumatic hematomas.Classification code: 06-00.
24. Central Venous Catheter Positioning System: Consists of Host Computer, Electrocardiogram Module, Monitoring Module and Accessories.During the central venous catheter insertion operation, doctors are guided to locate the distal end of the atrial catheter by monitoring the changes of patients' ECG waveforms.Before or after the operation, the monitoring module can monitor the vital sign parameters such as ECG, pulse oxygen saturation, pulse rate, non-invasive blood pressure and body temperature of the patient.Classification code: 07-03.
25. Auxiliary evaluation system for upper gastrointestinal diseases: mainly composed of host computer, liquid crystal display, video acquisition line and software.Connected with the image processor of the upper digestive tract electronic endoscope, the server in the host computer processes the received images by adopting technologies such as artificial intelligence, big data, deep learning and the like, and displays the images by a display.It can be used to identify four types of pathological changes, including atrophic gastritis, ulcer, polyp and stromal tumor, and give clinical conclusions such as the type, location and similarity of pathological changes for reference in diagnosis of pathological changes.Classification code: 07-00.
26. Radio frequency therapeutic instrument: mainly composed of main machine and therapeutic electrode.Radio frequency current generated by the equipment is transmitted to the body through the contact surface of the treatment electrode to achieve the effects of relieving pain, relaxing muscles, reducing edema and the like.It can be used for adjuvant treatment of acute and chronic muscle spasm, degenerative joint disease, soft tissue injury, female mastalgia, hyperplasia of mammary glands, dysmenorrhea, and abnormal menstrual cycle.Classification code: 09-07.
27. ECG analysis software: software products.The depth learning algorithm (convolution neural network) is used to calculate the twelve channels of ECG data collected by electrocardiograph, give the analysis results of symptoms such as ventricular hypertrophy, atrial load, atrioventricular/intracardiac conduction block, myocardial injury, myocardial infarction, arrhythmia, etc., and judge the heart beat type and whether there are ST segment and T wave changes, etc.Classification code: 21-04.
28. Anaesthesia depth monitor: It consists of host, power adapter, lead wire and functional grounding wire.The equipment collects the patient's brain wave data, and obtains the anesthesia depth index value after calculation and processing by the host computer, and monitors the parameter.Classification code: 07-04.
29. Remote ultrasonic diagnosis system: it consists of operation control system, audio and video system, motion execution system, ultrasonic system, etc.Through remote adjustment of parameters, the mechanical arm controls the probe to perform ultrasonic scanning of specific parts to form ultrasonic images for examination and diagnosis of abdominal, superficial, small organs, peripheral blood vessels and other parts. The body surface contacts and does not enter the human body.Classification code: 06-07.
30. Laparoscope control device: It consists of a host, a laparoscope posture control mechanism, a laparoscope clamping mechanism, a moving lifting mechanism and a swing arm mechanism.Used in laparoscopic minimally invasive surgery, the manipulator is used to hold the abdominal endoscope and control the position and direction of the endoscope.Classification code: 01-07.
31. Sentinel lymph node Raman localization system: It consists of Raman localizer (including spectrometer, laser and optical fiber probe) and suspended particles, wherein suspended particles consist of gold, 1,4-dithiol and silica.Before the operation, the solution containing suspended particles was injected by local tumor side to make it flow back to sentinel lymph nodes along lymphatic vessels for aggregation.During the operation, Raman spectrum of suspended particles is excited and detected by Raman locator to realize sentinel lymph node localization.Used for locating sentinel lymph nodes in cancer regions in tumor surgery, assisting doctors to judge the metastasis of lymph nodes in malignant tumor regions and guiding lymph node dissection.Classification code: 01-00.
32. Electric field therapeutic instrument: mainly composed of main machine and electrode plate.An alternating current electric field is applied to the scalp surface through the electrode sheet, and the electric field is utilized to prevent the proliferation of tumor cells and destroy the tumor cells.It can be used for adjuvant treatment of glioma.Classification code: 09-01.
33. Assistant Diagnostic Software for Mental Disorders: Software Products.It consists of a question-and-answer module and an analysis module.Patient questionnaire information is collected clinically, eigenvalues of different diagnosis results are extracted, and a diagnosis model is established through neural network in-depth learning.By answering the questionnaire, the characteristic values of the patients were obtained and compared with the diagnostic model to obtain the auxiliary diagnostic results.It is used to assist in diagnosis and differentiation of mental and psychological diseases such as depression or anxiety disorder, psychotic disorder, etc. It is used as an auxiliary reference for clinical diagnosis of doctors.Classification code: 21-04.
34. Nerve monitoring endotracheal intubation: mainly composed of catheter body, contact electrode, electrode connection line, inflatable cuff, cuff inflation tube and hypodermic needle.The product is connected with a nerve monitor, and electrical signals generated by the nerve monitor stimulate human nerves through contact electrodes, and myoelectric signals are fed back to the nerve monitor.It is used for intraoperative monitoring of laryngeal nerve activity and providing a smooth airway for patients.Classification code: 07-04.
35. Portable neurostimulator: mainly composed of control unit, mouthpiece electrode and charger.The patient's mouth contains a mouthpiece electrode, and the control unit generates a special array of electrical pulses to be transmitted to a specific region of the patient's tongue to stimulate trigeminal nerve and facial nerve to generate nerve impulses and activate neurons and structures corresponding to human body functions.The product is combined with exercise training, balance training, walking training, breathing and consciousness training to improve chronic balance defects caused by mild to moderate traumatic brain injury.Classification code: 09-01.
36. Instant vacuum automatic blood sampling instrument: it consists of mobile tube changing unit, plug mixing unit, needle feeding unit, vacuum pumping unit, blood collection tube rack, optical quantitative detection unit, electronic control unit and blood overflow detection unit.The negative pressure generated by the negative pressure pump in the machine is used to collect blood from the human body, and the amount of blood collected is quantitatively detected by the optical detection system. After blood collection, the blood collection vessel is rotated to mix the blood and the additive in the tube evenly, and finally a blood sample meeting the requirements is obtained.Clinically, it is used for collecting venous blood of patients in hospital outpatient clinics and blood collection centers.Classification code: 22-11.
37. Library kit for gene sequencing: consists of library amplification reaction solution, buffer solution, DNA ligase and sequence linker.For processing human genomic DNA extracted from peripheral blood or paraffin-embedded tissue and the target sequence of the sample library generated thereby.It is used together with Illumina second-generation sequencer and sequencing reaction universal kit.No human genome sequencing or de novo sequencing is required.Classification code: 6840.
38. Ubiquitin carboxy-terminal hydrolase -1(UCH-L1) assay kit (magnetic particle chemiluminescence method): consists of ubiquitin carboxy-terminal hydrolase -1(UCH-L1) assay reagent strip, quality control product, calibration product and desiccant.It is used for the determination of UCH-L1 content in human serum samples, and can be clinically used for monitoring the occurrence and development process of neurodegenerative diseases, tumor, auxiliary diagnosis of brain trauma, etc.Classification code: 6840.
39. trichomonas vaginalis (T.V) secreted protein detection kit (colloidal gold method): it consists of T.V secreted protein detection test strip/card and sample buffer.Used for qualitative detection of trichomonas vaginalis secretory protein in female vaginal secretions and urine samples, and clinically used for auxiliary diagnosis of trichomonas infection in female vaginitis.Classification code: 6840.
40. Candida albicans secreted protein detection kit (colloidal gold method: composed of Candida albicans secreted protein detection test strip/C.Alb and sample buffer solution).Used for qualitative detection of candida secretory protein in female vaginal secretion samples and urine samples, and clinically used for auxiliary diagnosis of female candida vaginitis infection.Classification code: 6840.
41. helicobacter pylori (H.P) secreted protein detection kit (colloidal gold method): composed of helicobacter pylori (H.P) secreted protein detection test strip/test card and sample buffer.Used for qualitative detection of helicobacter pylori secretory protein in stool samples, and clinically used for auxiliary diagnosis of inflammation such as gastritis, digestive tract ulcer, duodenal ulcer, etc.Classification code: 6840.
42. Mycobacterium tuberculosis (TB) secreted protein detection kit (colloidal gold method): consists of Mycobacterium tuberculosis (TB) secreted protein detection test strip/test card and sample buffer.Used for qualitative detection of mycobacterium tuberculosis secretory protein in mycobacterium tuberculosis culture medium and sputum, and clinically used for auxiliary diagnosis of tuberculosis.Classification code: 6840.
43. Human peripheral blood leukocyte removal kit (negative immunomagnetic particle method): consists of blood pretreatment solution A, blood pretreatment solution B, separation solution and magnetic particle suspension.Used to remove leukocytes from whole blood in vitro for downstream analysis.Classification code: 6840.
44.IL-1β, IL-6, IL-8, IL-10, TNF-α assay kit (flow cytometry method): consists of capture microsphere mixed solution, quantitative standard, fluorescence detection reagent, calibration microsphere, calibration liquid A, calibration liquid B, sample diluent, microsphere buffer.It is used to detect the contents of IL-1β, IL-6, IL-8, IL-10 and TNF-α proteins in serum or plasma.It is clinically used for auxiliary diagnosis, medication and prognosis intervention of diseases.Classification code: 6840.
45.IL-2, IL-4, IL-17, IFN-γ assay kit (flow cytometry method): consists of capture microsphere mixed solution, quantitative standard, fluorescence detection reagent, calibration microsphere, calibration liquid A, calibration liquid B, sample diluent and microsphere buffer.It is used to detect the contents of IL-2, IL-4, IL-17 and IFN-γ proteins in serum or plasma.It is clinically used for auxiliary diagnosis, medication and prognosis intervention of diseases.Classification code: 6840.
46.HER2 three-in-one pathological quality control tablet: composed of 3 formalin-fixed and paraffin-embedded human breast cancer cell line samples from different sources.On a specific detection system, the quality control sheet is used together with HER2 DNA probe and chromosome 17 probe to semi-quantitatively monitor the probe performance of in situ hybridization (ISH).Classification code: 6840.
47.HER-2 Four-in-One Pathological Quality Control Tablet: It consists of 4 formalin-fixed and paraffin-embedded human breast cancer cell lines from different sources.It is used to monitor the immunohistochemical staining performance of anti -c-erbB-2/HER-2 antibody.Classification code: 6840.
48.HER2 double staining in situ hybridization three-in-one pathological quality control tablet: it consists of 3 tumor cell lines from different sources fixed in formalin and embedded in paraffin.On a special detection system, it is used together with a specific probe for quality control of clinical detection experiments.Classification code: 6840.
49. DNP antibody reagent: composed of DNP rabbit monoclonal antibody, buffer containing carrier protein and preservative.Clinically, it is used together with HER2/CEN17 double probe detection kit to detect DNP labeled HER2 DNA probe and chromosome 17 probe.Classification code: 6840.
50. Chemokine pentad detection kit (flow cytometry method): consists of capture microsphere mixed solution (polystyrene, anti-human CXCL8/IL-8 monoclonal antibody, anti-human CCL5/RANTES monoclonal antibody, anti-human CXCL9/MIG monoclonal antibody, anti-human CCL2/MCP-1 monoclonal antibody, anti-human CXCL10/IP-10 monoclonal antibody), quantitative standard (human recombinant protein lyophilized powder),Fluorescence detection reagent (PE labeled microsphere detection antibody), calibration microsphere (polystyrene magnetic particle microsphere), calibration solution A (phycoerythrin fluorescein labeled control antibody), calibration solution B (fluorescein isothiocyanate labeled control antibody), and sample diluent (buffer solution, sodium chloride, fetal bovine serum, preservative).It is used in combination with flow cytometer to detect the contents of five chemokines (CXCL8/IL-8, CCL5/RANTES, CXCL9/MIG, CCL2/MCP-1, CXCL10/IP-10) in samples.It is clinically used to evaluate the immune function of the body.Classification code: 6840.
51. Gene sequencing library kit (transposase method): consists of reagent 1 (fragmentation buffer, fragmentation enzyme, amplification buffer, amplification enzyme, eluent), reagent 2 (label primer), and reagent 3 (magnetic beads).Used in combination with universal reagents for gene sequencing and Illumina gene sequencing system, it is used for processing human genome DNA, single cell amplification products, cDNA and library construction.Classification code: 6840.
52. Sequencing kit for gene sequencing: composed of dNTP, reactive enzyme, sequencing primer, buffer, etc.It is used together with a library kit for gene sequencing, a template kit for gene sequencing and a chip for gene sequencing combined with an Ion torrent sequencing platform for processing human genome DNA extracted from tissue samples and target sequences of sample libraries generated thereby.Not the whole human genome or de novo sequencing.Classification code: 6840.
53.AML/MDS probe chip (in situ hybridization method): consists of AML/MDS probe chip, sample chip and chip hybridization buffer.Through a hybridization test, qualitative detection of P53, PML/RARA, KMT2A, AML1/ETO, 5q31(EGR1/TERT), CBFB/MYH11, 7q31(D7S486/CSP7) and D20S108/CSP8 genes in the samples was conducted.It is clinically used for auxiliary diagnosis of leukemia.Classification code: 6840.
54.ALL probe chip (in situ hybridization method): It consists of ALL probe chip, sample chip and chip hybridization buffer.Through a hybridization test, the samples were qualitatively tested for abnormalities in MYC, ETV6/AML1, IGH, BCR/ABL1(DF), E2A, CDKN2A/CSP17, KMT2A, and 4/10 genes.It is clinically used to guide the administration of tyrosine kinase inhibitors.Classification code: 6840.
55.MPN probe chip (in situ hybridization method): composed of MPN probe chip, sample sheet and chip hybridization buffer.Through a hybridization test, qualitatively detect whether there are abnormalities in FGFR1, PDGFRB, PDGFRA, BCR/ABL1(DF) genes in the sample.It is clinically used to guide the administration of tyrosine kinase inhibitors.Classification code: 6840. ALL probe chip (in situ hybridization method): composed of ph-like ALL probe chip, sample piece and chip hybridization buffer.Through a hybridization test, qualitative detection of CRLF2, PDGFRB, ABL1, CSF1R, BCR/ABL1(DF), ABL2, JAK2, EPOR genes in the sample is carried out.Clinically used for auxiliary diagnosis of Ph-like acute lymphoblastic leukemia.Classification code: 6840.
57. Full-automatic blood bank system: composed of sample feeder, conveyor, punching mechanism, incubator, centrifuge, reader, bar code scanner and computer control software.Clinically, it is used to detect ABO and RhD blood group antigen test cards, ABO and Rh(D) blood group typing test cards, ABO and Rh blood group antigen test cards and anti-human globulin test cards produced by our company.Realize automatic sample distribution, reagent distribution, incubation, centrifugation, result interpretation (negative, positive) and storage.Classification code: 22-01.
58. Neutral detection card (microcolumn gel method): it is mainly composed of 8 microporous tubes, dextran polymers and preservatives.The separation of agglutinated red blood cells and non-agglutinated red blood cells is realized through antigen, antibody reaction and molecular sieve action.It is clinically used to detect agglutination of red blood cells.Classification code: 6840.
59. Library Kit for Gene Sequencing (DNA Interrupt Ligation Method): It consists of terminal repair mixture, terminal repair buffer, T4 DNA ligase, T4 DNA ligase buffer, PCR mixture, adapter suitable for Illumina sequencing platform, universal primer and sequence tag primer 1-12.Construction of DNA Sequencing Library for Illumina Second Generation Sequencing Platform.Classification code: 6840.
60. Library preparation kit for sequencing: mainly composed of fragment capture reaction solution, primer digestive enzyme, ligation buffer, DNA ligase, library amplification reaction solution, amplification PCR primer, eluent, specific linker mixture 1-96, DNA purification magnetic beads, etc.The target gene is amplified by multiple PCR technology, and then the amplified product is cut by primer digestive enzyme to form a flat end which can be connected with a specific linker mixed solution, and a library which can be used for an Ion torrent sequencing platform is formed under the action of a connection buffer solution and DNA ligase.Classification code: 6840.
61. Epidermal Growth Factor Receptor v Ⅲ(EGFR v Ⅲ) Antibody Reagent (Immunohistochemical Method): Consists of Epidermal Growth Factor Receptor v Ⅲ(EGFR v Ⅲ) Antibody and Buffer.Can be used for qualitative detection of EGFR v Ⅲ protein in human tissues fixed by 10% neutral buffered formalin and embedded in paraffin in vitro, and can be clinically applied to novel diagnosis and treatment targets of various tumors (such as breast cancer, liver cancer and colon cancer).Classification code: 6840.
62. Tyrosine Kinase Receptor (ROS1) Antibody Reagent (Immunohistochemical Method): Consists of Tyrosine Kinase Receptor (ROS1) Antibody Reagent.Clinically, it has diagnostic value for non-small cell lung cancer or is used for screening lung cancer with ROS1 gene rearrangement.Classification code: 6840.
63. Mycobacterium tuberculosis secretory protein (Ag85B) (immunohistochemical method): composed of antibody reagent of Mycobacterium tuberculosis secretory protein (Ag85B).Immunohistochemical staining on the basis of routine staining is clinically valuable for pathological diagnosis of tuberculosis.Classification code: 6840.
64. Epidermal Growth Factor Receptor L858R(EGFR L858R) Mutant Antibody Reagent (Immunohistochemical Method): Consists of EGFR L858R Mutant Antibody and Buffer.Can be used for qualitative detection of EGFR L858R protein in human tissues fixed by 10% neutral buffered formalin and embedded in paraffin, and has clinical diagnostic value for non-small cell lung cancer.Classification code: 6840.
65.MDS probe chip (in situ hybridization method): it consists of MDS probe chip, sample chip and chip hybridization buffer.Through a hybridization test, qualitative detection of 5q33 (csf1r/terrt), D20S108, 5q31 (egr1/terrt), X/Y, 7q31(D7S522/CSP7) and 7q31(D7S486/CSP7) genes in the sample was conducted.It is clinically used for auxiliary diagnosis of myelodysplastic syndrome.Classification code: 6840.
66.IFN-γ/IL-4 detection reagent (flow cytometry): composed of phosphate buffer (PBS) and fluorescent FITC/PE labeled IFN-γ/IL-4 monoclonal antibody.IFN-γ and IL-4 in human biological samples were detected by flow cytometry, which was clinically used in the auxiliary diagnosis of chronic lymphocytic leukemia (CLL) and infectious diseases.Classification code: 6840.
67. The library construction and purification kit comprises T4 DNA polymerase, T4 polynucleotide kinase, Taq DNA polymerase, T4 DNA ligase, T4 ligase buffer, adenine nucleoside triphosphate, polyethylene glycol 4000, polyethylene glycol 8000, sodium chloride deoxyribonucleoside triphosphate, deionized water, PCR primers, high fidelity PCR enzyme and carboxyl magnetic beads.It is used in the construction and purification of Illumina second generation sequencing library.Classification code: 6840.
68. The library preparation kit comprises buffer solution 1, reaction enzyme 1, buffer solution 2, reaction enzyme 2, linker label, PCR amplification mixed solution, PCR primer mixed solution and instructions.Construction of DNA Sequencing Library for Illumina Sequencing Platform.Classification code: 6840.
69. Library kit for gene sequencing: consists of PCR mixed solution, universal primers suitable for Illumina sequencing platform and sequence tag primers 1-12.Through one-step PCR amplification, DNA library construction for Illumina second generation sequence platform is obtained, and sample sequence information can be obtained according to Index sequence in amplification primers.It is not suitable for human genome sequencing.Classification code: 6840.
II. Products Managed by Class II Medical Devices (122)
1. Medical female urinal: composed of urinal and applicator.The urinal consists of a flexible ring, a rigid part and a withdrawal rope.The applicator consists of a tube body and a push rod.Made of polymer materials.Non-sterile supply.When in use, the urinal stopper is sent into the vagina through the applicator, so that the flexible ring supports the inner vaginal wall in the area below the bladder neck.During urination, the weight of the bladder will exert pressure on the flexible ring. Through conduction, the rigid part of the urine stopper will force the urethra to close to reduce the risk of urine leakage.Can be used for treating female stress urinary incontinence or mixed urinary incontinence.Classification code: 18-04.
2. Sterile V-shaped reticular skin graft processing mold: 280mm×78.8mm cuboid with evenly distributed V-shaped grooves on the surface and symmetrical left and right.It is made of high molecular materials, provided aseptically and used once.It is used to assist in cutting the transplanted skin into a net shape in the operation of taking and skin grafting.When in use, it is used in conjunction with a medical skin rolling machine, the transplanted skin is placed on the product, the transplanted skin contacted with the blade of the medical skin rolling machine is cut off through the operation of the medical skin rolling machine, and the rest of the transplanted skin is reticular.Classification code: 02-15.
3. Medical skin rolling plate: plate-shaped.It is made of high molecular styrene butadiene block copolymer and is provided aseptically for single use.It is used in skin grafting and extraction, and is used in conjunction with a skin rolling machine, and is placed on the skin rolling machine as a skin carrier for skin rolling treatment.Classification code: 02-15.
4. Disposable negative pressure drainage set: it consists of drainage bottle, suction bottle (including air bag), wound drainage drainage tube (composed of wound drainage tube and puncture needle), drainage tube with Y-shaped coupling device, placement bag and/or coupling device (used for coupling bottle and catheter).Aseptic supply.It is used for wound or incision drainage and plays a role as negative pressure conduction medium and/or guiding and collecting drainage liquid.The puncture needle does not belong to ventricle puncture needle, lumbar puncture needle and iliac puncture needle.Classification code: 14-06.
5. Disposable negative pressure drainage device set: consists of collection container, connector, drainage tube, connecting tube, clip, hanging clip, guide needle and protective sleeve.Aseptic supply.It is used for drainage of body surface wounds or incisions and plays a role as negative pressure conduction medium and/or guiding and collecting drainage liquid.The guiding needle does not belong to ventricle puncture needle, lumbar puncture needle and iliac puncture needle.Classification code: 14-06.
6. Disposable liquid medicine transfer device: divided into C type and D type.The C type consists of a needle protection sleeve, a bottle stopper puncture device, a lateral liquid injection hole, a hand-held end, an elastic liquid pipe clamp, a pipe tail joint, a flow blocking cap, a liquid pipe, a liquid medicine adapter and a disposable liquid medicine transfer device.Type D consists of luer connector, silicone spring connector and cap.Aseptic supply.It can be used for transfer between different drugs to realize drug dissolution before infusion, dispensing or multi-dosage drug combination infusion, etc.Not as an accessory to the designated relay pump.Classification code: 14-02.
7. Sample suction or discharge handle for assisted reproduction: composed of handle and silica gel balloon.Made of stainless steel.Non-sterile, reusable.Used in conjunction with plastic medical straws.It is used in assisted reproduction technology to remove cumulus from oocytes and realize transfer of cells, embryos and oocytes between plates.Classification code: 18-07.
8. Gun-shaped tool for sucking or discharging samples for assisted reproduction: composed of plunger wire, syringe, chuck, thumb rest and bracket.Made of stainless steel.Non-sterile, reusable.Used in conjunction with plastic medical straws.Used for sucking or discharging samples in assisted reproduction technology.Classification code: 18-07.
9. Medical Strabismus Correction Glasses: Consists of Epidural Pressure Sticking Triangular Prism Sheet, Spherical Lens (or Flat Lens) and Glasses Frame.Through the deflection of the incident light by the microprism, the hard film pressed on the triangular prism lens can optically compensate the strabismus eyeball, thereby restoring the visual axis of the strabismus eyeball to a normal position.Spherical lens optically compensates ametropia eyeball through concave lens or convex lens.It can be used for the treatment of concomitant strabismus, paralytic strabismus and other small degree strabismus diseases.Classification code: 19-06.
10. Ophthalmic laser optical fiber indicator: consists of light emitting module, housing, lithium battery, function indicator lamp, power supply and mode switch, SC/APC optical fiber interface and power adapter.It is used in open angle glaucoma surgery (Schlemmer's tube plasty) in conjunction with ophthalmic fiber optic catheter to indicate the position of the ophthalmic fiber optic catheter tip in Schlemmer's tube.Classification code: 16-05.
11. Disposable wound auxiliary suturing device: composed of shell, main shaft, needle holder, 1.25mm puncture needle (with lead slot), thread pulling button and positioning rubber pad.Sutures are not included.The puncture needle is made of stainless steel and other parts are made of polymer.Aseptic, disposable.It is used to assist in threading the suture line on the wound surface in case of trauma or surgical wound, so as to facilitate the full-thickness suture of the skin (epidermis, dermis, subcutaneous tissue).Classification code: 02-15.
12. Disposable vaginal dilator with fluorescent lamp: composed of upper leaf, lower leaf, handle, 3.0 volt button battery, fluorescent light emitting diode and switch.Aseptic, disposable.For the detection of female cervix, insert the vagina and expose the cervix, then smear the cervix with 3-5% acetic acid solution, then light up the fluorescent light emitting diode through the dilator tail switch, and then check the color of the smeared part of the cervix under the irradiation of the fluorescent light source by naked eyes so as to preliminarily judge whether it is infected with HPV lesions.The tissue in the normal part is blue, the tissue in the lesion part is white, and there is a clear and dense blue-white scale border in the transformation area from normal to lesion.Classification code: 18-01.
13. Disposable percutaneous renal puncture kit: consisting of dilation tube, cannula, superhard coated guidewire (coating composition is polytetrafluoroethylene), puncture needle (with needle core) and Foley tube (balloon drainage tube).Aseptic, disposable.Instruments used in percutaneous renal puncture and laparoscopic surgery for patients with renal calculi or hydronephrosis.It is used to establish a working channel for percutaneous (non-vascular) access of the instrument to the renal pelvis and to drain hydronephrosis or waste liquid to the outside of the body.When in use, after percutaneous puncture with a puncture needle with a needle core, the needle core is withdrawn, the superhard coated guide wire enters the renal pelvis position through the puncture needle, then the expansion tube is expanded step by step along the guide wire path according to the specification sequence from small to large, and finally the expansion tube with a sleeve is withdrawn from the expansion tube, the guide wire and the sleeve according to the routine after the expansion is completed, thereby establishing a working channel for the instrument to enter, and the Foley tube is placed into the position needing drainage through the sleeve for drainage.Classification code: 02-12.
14. balloon catheter kit for Meckel Cave expansion: composed of balloon catheter and puncture probe.The balloon catheter consists of a tube body, a compression balloon, a luer joint and a filling device.The puncture probe consists of an inner needle and an outer sheath.When in use, under the monitoring of X-ray fluoroscopy, the puncture probe is punctured to the foramen ovale and then withdrawn, leaving an outer sheath. The balloon is introduced into the Mike cavity through the outer sheath, then a contrast contrast agent is injected to fill the balloon, and the Mike cavity is compressed through the expansion of the balloon, so that nerve fibers causing trigeminal neuralgia are relieved of compression, and damage is compressed through the expanded balloon, thus being used for treating trigeminal neuralgia.The product does not contact the blood circulation system and the central nervous system.Classification code: 03-13.
15. Oral administration device: composed of oral administration syringe and adapter plug.Oral administration syringe consists of lumen (with adapter interface), push rod and dose regulator (with stop function).No drugs, non-sterile, reusable.It has dose control function.For oral administration of oral suspension containing rivaroxaban.Classification code: 14-07.
16. Transnasal cell drug delivery catheter: composed of transplantation handle and transplantation hose.Made of polymer materials.Aseptic, disposable.When in use, the transplantation hose is penetrated into the nasal ethmoid sinus region for injecting cellular medicine into the nasal ethmoid sinus region through the transplantation hose, and the cellular medicine can enter the brain through the olfactory nerve.Classification code: 14-07.
17. Oral administration device: composed of outer sleeve, piston and vial adapter.Non-sterile, reusable.When in use, the product is connected with the medicine bottle, milliliters (ml) of liquid medicine corresponding to the prescription dose are extracted from the medicine bottle, and the sucked liquid medicine is taken by the patient.It has dose control function.It is used for children and teenagers to take oral solution drugs together.The oral administration device is plastic sealed with a transparent bag and packaged in the same medicine box with the medicine syrup. The medicine in the auxiliary medicine box is administered and is not sold separately to medical institutions.It is suggested to manage medical devices according to Class II, with classification code: 14-07.
18. Fat filtering device set for transplantation: consisting of filtering device, catheter clip, outlet tube, waste liquid bag, luer connector, inlet tube, puncture needle head and protective sleeve.Aseptic supply.When in use, adipose tissue taken from a human body is introduced into a filter device, and adipose tissue cells are filtered through vibration by manually shaking the filter device.When used in fat transplantation surgery, waste liquid, blood and other tissue fragments from adipose tissue cells of human body are filtered out.Classification code: 02-15.
19. Zirconia porcelain block coloring agent for all-ceramic denture: composed of coloring agent, solvent and additive, wherein the coloring agent is iron ion and rare earth ion, the solvent is water, and the additive is polyethylene glycol.It is used for dyeing zirconia base crown, a dental zirconia ceramic product, to obtain a color similar to that of natural dentin.After dyeing, it is sintered at high temperature, and finally solidified on the crown surface of zirconia substrate are iron and rare earth elements.Classification code: 17-06.
20. Customized fixed denture (3D laser casting cobalt-chromium alloy porcelain crown and bridge): inner crown and outer denture porcelain powder (i.e. porcelain powder, paste, glaze powder and glaze water) made of cobalt-chromium alloy powder are sintered by 3D laser casting printing technology.Manufactured for the use of registered denture materials.It is used for fixed restoration of tooth body, dentition loss or defect.Classification code: 17-06.
21. Medical ciliary muscle adjusting function training flip racket: consists of positive lens, negative lens, plastic frame and reverse button.Passive products.When a user normally observes a target with a fixed distance, the front lens of the flip-flop is placed in front of the eyes so that the target is imaged in front of the retina of the eye. The eyes of the user automatically adjust to image the target on the retina of the eye, and the adjustment naturally relaxes the ciliary muscle.After placing the negative lens of the flip-flop in front of the eyes to image the target on the retina of the eye, the user's eye will automatically adjust to image the target on the retina of the eye, and the adjustment will naturally tighten the ciliary muscle.Repeat the above operation to make the ciliary muscle of the user's eye undergo adjustment training.It is used for patients with insufficient ciliary muscle regulation function to train ciliary muscle regulation function and relieve visual fatigue.Classification code: 16-05.
22. Pelvic fixing tourniquet: composed of fixing belt, reinforcing belt, snap-on fixing clip, air bag and air pump.Used for hemostasis of pelvic fracture.By inflating the air bag on the fixing belt and controlling the pressure, the bleeding point is pressed and the blood flow is blocked, so as to achieve the purpose of hemostasis.At the same time, the fracture site can be fixed and supported by tightening the reinforcing band to prevent secondary injury to the injured.Classification code: 14-11.
23. Medical pneumatic pelvic fixing belt: composed of fixing belt, manual air bag, pressure gauge and stop valve.Non-sterile, reusable.When in use, the fixing belt is inflated by a manual air bag, and transverse pressure is applied to the pelvis through the inflated fixing belt so as to push the fixing belt back to the initial position.It is used to fix and stabilize the pelvic fracture site of the patient by emergency medical rescue (EMS) personnel before admission.Classification code: 04-13.
24. Stomatology Gap Hat: Same shape as metal cap.Made of polymer materials.Non-sterile, disposable.It is used in the dental technician's room as the plastic inner crown for the upper restoration of the outer crown, which is completely burnt out after being heated in the process of making the metal crown.Classification code: 17-08.
25. Medical nasal filter plug: composed of core tube, filter screen, outer sleeve and connecting wire.The core tube and filter screen are made of stainless steel.The jacket and connecting wire are made of polymer materials.Before use, clean and disinfect with 75% alcohol cotton ball.Can be reused.When in use, it is placed in the nostril and is level with the nostril.It is used for patients with allergic rhinitis and allergic asthma, and can block inhalant insoluble particles and microorganisms from entering nasal cavity through a filter screen to relieve related symptoms caused by allergic rhinitis and allergic asthma.Classification code: 14-16.
26. Medical wound irrigation machine: it consists of main machine, water inlet pipe, irrigation pipe, spray nozzle, splash guard, irrigation handle, special irrigation spray gun and power cord.When in use, the flushing liquid is added, and is used for spraying the flushing liquid onto the wound surface of common trauma for flushing by controlling the water flow, water pressure, water temperature cleaning time and cleaning process.After the nozzle and splash shield are used, they should be disinfected.Classification code: 14-07.
27. Disposable RF plasma ophthalmic surgical electrode: composed of double electrodes, insulating sleeve, plastic handle, cable, drip tube and/or suction tube and plug.Made of metal and polymer materials.Aseptic, disposable.It is used in conjunction with radio frequency plasma surgery mainframe, and is used for cutting or coagulating the ocular surface and canthus of human body in ophthalmic surgery.Classification code: 16-05.
28. Medical personalized orthopedic surgery guide plate: it is made by 3D reconstruction based on the data obtained from imaging and 3D printing.Made of high molecular material (ultra-high molecular polyethylene nylon powder).During use, it will not contact the central nervous system or the blood circulation system and will not be provided aseptically.It is used for positioning, guiding, evaluating or providing datum plane in orthopedic surgery of pelvis, limbs, head and spine.Classification code: 04-16.
29. Special drug dissolving device for dispensing robot: composed of outer sleeve, core rod, piston, needle tube, small needle sleeve and protective cap.Aseptic supply.When being used for intelligent dispensing robots to dispense drugs, aspirate liquid to prepare drugs or transfer drugs, and shall not be used for human body puncture or injection.Classification code: 14-02.
30. Ultraclean Dispensing Device: Consists of a box body, an operation console (handle), a fan, a prefilter, a high-efficiency filter, a drug dissolving device and an electric appliance controller.It can provide a partially sealed 100-level clean environment for the drug dissolving device, and is used for dissolving and preparing intravenous drugs in wards, nurse stations and intravenous drug centralized allocation centers.It is not used in pharmacy.Classification code: 14-02.
31. Medical gel dressing: gel made of hydroxyethyl cellulose, propylene glycol and purified water.Aseptic supply.By forming a barrier at the damaged part of the skin;At the same time, the wound surface can be kept in a certain moist state to promote wound healing.It is used for nursing superficial wounds and wounds after micro-plastic surgery.Classification code: 14-10.
32. Kaolin particle hemostatic dressing: powdered particles with a similar molecular sieve network structure are prepared from natural mineral kaolin through a series of processes such as acrylate copolymerization and surface calcium addition.Aseptic, disposable.When in use, it is applied to the wound, and absorbs liquid components in blood, thus causing blood macromolecular substances to adsorb on the surface of particles to form mechanical blood clots, while coagulation factors promote blood coagulation due to concentration and aggregation.It is used for nursing and hemostasis of non-chronic wounds on the body surface, and is not used in vivo.The contained components are not absorbed by the human body.Classification code: 14-10.
33. Single-use negative pressure wound protection material: it consists of dressing at the liquid absorption part and suction cup catheter at the drainage part.Aseptic supply.Used in combination with negative pressure suction equipment, it can be used for drainage of surface non-chronic wounds such as suture wounds, mechanical wounds, cut wounds, superficial II degree burn wounds and the like after surgery by transferring negative pressure to wounds to promote healing.Classification code: 14-06.
34. Single-use biopsy gun (including biopsy needle): composed of inner needle, outer needle, sheath, inner needle holder, spring, power device and excitation device.Non-sterile, reusable.Sterilization shall be carried out by the user before use.It is used to obtain specimens from human tissues such as liver, kidney, prostate, breast, spleen, lymph nodes, soft tissue tumors, etc. for biopsy, but is not suitable for bone marrow biopsy.Classification code: 14-01.
35. Disposable external suction tube: it is made up of tube body, flow control switch and valve, and is tubular in form.Aseptic, disposable.When in use, a collection container of a negative pressure suction pump and a thrombus suction catheter (intravascular catheter) are respectively connected for sucking waste liquid (blood and thrombus) in vitro during surgery.No direct contact with human body.Classification code: 14-06.
36. Cerebrovascular Thrombus Suction System: Consists of Suction Pump and Disposable Collection Container with Intermediate Pipeline for External Connection.Aseptic supply.When in use, the intermediate pipeline is connected with a thrombus suction catheter inserted into the cerebrovascular system outside the body, negative pressure is generated by the suction pump, and continuous suction is carried out for removing occlusive thrombus from the cerebrovascular system, so as to help patients suffering from acute ischemic stroke secondary to intracranial large vessel occlusive diseases (internal carotid artery, M1 and M2 segments of middle cerebral artery, basilar artery and vertebral artery) to rebuild blood supply within 8 hours of symptom onset.Classification code: 14-06.
37. Medical UV protective glasses: composed of two eyepieces and a rubber connecting mechanism.Ultraviolet rays with wavelengths of 280-400 nm are absorbed through eyepieces for skin disease patients to protect eyes from ultraviolet radiation during ultraviolet phototherapy.Classification code: 16-06.
38. Image viewing software: software products.For viewing and storing digital pathological images.When combined with remote desktop software solution, it can be used for viewing remote digital pathological images.When the stored images are viewed, they can be used to assist remote consultation.Classification code: 21-02.
39. Intestinal hydrotherapy machine: mainly composed of heating device, liquid injection pipe fitting, filter, control and detection components and liquid medicine bottle.The composition of the product does not contain liquid medicine.The equipment injects filtered water into the colon of a human body through a liquid injection pipe fitting, cleans and washes the intestines, removes intestinal endotoxin, and then injects special liquid medicine for auxiliary treatment.It is used for cleaning intestinal tract in medical institutions and injecting special liquid medicine for adjuvant treatment of corresponding diseases.Referring to the management category of " intestinal hydrotherapy machine" in the classification catalogue, it is recommended to manage according to Class II medical devices.Classification code: 09-08.
40. Vertebral traction therapeutic instrument: it consists of top structure, connecting rod, disc, automatic lock, foaming washer, metal bolt, hanging rope and hook.When in use, the head of the patient extends into the equipment from below the chassis and is supported on a foaming washer, and the spine is stretched by the foaming washer.It can be used for improving humpback, recovering physiological curvature of cervical vertebra and lumbar vertebra, and enhancing masseter muscle resultant force.Classification code: 09-04.
41. Medical infrared thermometer: It consists of temperature display screen, infrared sensor, shell, connecting wire and software.The infrared principle is adopted to process the received heat radiation signal and obtain the measurement result.It is used for measuring the body temperature of patients in medical institutions.Classification code: 07-03.
42. Dry eye auxiliary diagnosis software: software products.It consists of a blink image acquisition and processing module, a server-side database management module and a client-side data display module.The blink image acquisition and processing module is used to capture and identify eye blink/blink actions from video images, record each blink/blink time in the monitoring period and calculate the frequency.The calculation results are used for auxiliary diagnosis of dry eye.Classification code: 21-04.
43. Dry eye rehabilitation training instrument: composed of host computer, embedded software, power adapter and charging line.Patients are guided by embedded software in the host computer, and the patients follow the prompts of voice and indicator lights to blink or massage for rehabilitation training to relieve dry eye symptoms.Classification code: 19-01.
44. Bracket for assisting penis: composed of support ring, support ring buckle, support rod and glans penis sleeve.Relying on the bow-shaped elastic action of the connecting support rod sleeved between the supporting ring at the root of the penis and the glans penis sleeve, the utility model is used for helping the erectile dysfunction patient to recover the sexual ability.Classification code: 09-04.
45. Trace element analyzer: composed of host computer and software.Using spectrophotometry, the content of minerals and heavy metals in skin can be obtained by measuring the measuring points on the palm.It is used to detect mineral and heavy metal content in human skin and assist in screening diseases caused by heavy metal poisoning or mineral imbalance in human body.Classification code: 07-00.
46. Pulmonary functional electrical impedance imaging system: mainly composed of host computer, lead wire and electrical impedance sensor.The voltage on the body surface is measured by injecting a known current into a specific part of the human body, and the impedance distribution of various tissues and organs inside the human body under the action of an electric field is calculated by using the measured voltage value to obtain the required tomographic imaging.It is used to monitor the respiratory distribution and pulmonary ventilation of patients in supine, prone and lateral positions, and to continuously and non-invasively monitor the local changes of pulmonary volume.:07-02。
47. Semiconductor laser therapeutic instrument: mainly composed of main machine (hood), controller and adapter.Heat generated by laser irradiation on the scalp stimulates scalp cell tissue.Can be used for treating male androgenetic alopecia and promoting hair growth.The output laser is classified as 3R according to GB 7247.1-2012 and belongs to weak laser.Classification code: 09-03.
48. Electric scab grinder: mainly composed of grinding head, scab grinder body, electric motor and control device.A motor is used to drive a grinding head installed at the front end to grind scabs on burned parts.Classification code: 01-10.
49. Intraoperative clean-up and wound water delivery pump: composed of main machine and pump head.The main machine consists of a power supply circuit, a control circuit, a stepping motor and a shell.The pump head consists of a roller and an upper pressing plate.Silicone hose is not included.The rotating roller squeezes the silicone tube to complete the fluid delivery.The device is connected with a bipolar electrocoagulation dripping accessory of a specific high-frequency surgical device through a lead wire, and the current control device for detecting the dripping accessory is started and stopped.Which is use for providing pow for liquid delivery of debridement water and controlling that liquid flow rate in surgery.Classification code: 01-03.
50. Snore suppressor: It consists of silica gel shell, silica gel earplug, microphone, horn, motor, battery and main board.When in use, it is worn on ears to capture snoring signals and skull vibration signals of human snoring to identify snoring, and physical intervention consisting of sound emitted by speakers and vibration emitted by motors acts on ears.Used to suppress snoring.Classification code: 09-00.
51. Network anesthesia monitoring information management software: software products.It is used to process medical information system data and connected monitor information data (heart rate, blood pressure and blood oxygen saturation), and to analyze and statistically output these data for reference when doctors make treatment plans or other medical decisions. It does not have the functions of administration route, dose calculation and monitor parameter adjustment.Classification code: 21-03.
52. Electroencephalogram electrode cap: mainly composed of acquisition electrode, electrode fixing cap, conductive wire and connector.Can be matched with various electroencephalograms and used for collecting human brain electrical signals and transmitting the human brain electrical signals to the electroencephalograms.Classification code: 07-10.
53. Pelvic floor rehabilitation training instrument: mainly composed of cushion and pressure sensing device.The pressure of perineum is measured by probe with sensor, and pelvic floor muscle active contraction training is assisted by biofeedback to improve pelvic floor dysfunction.Classification code: 19-02.
54. Arm rehabilitation trainer: consists of finger cuff, finger guide bracket, spring and thumb system.Through the bending movement of fingers, the mechanical structure is driven, the spring force is applied to the arm, and the purpose of rehabilitation training is achieved through resistance resistance training.Classification code: 19-02.
55. hypochlorous acid generator: it mainly consists of main machine, dosing box (including hydrochloric acid dosing box and sodium hypochlorite dosing box, excluding hydrochloric acid and sodium hypochlorite) and clean water tank.It is used to generate hypochlorous acid disinfectant. Its disinfection objects include stethoscope, endoscope, surgical instruments and other medical instruments.Classification code: 11-03.
56. Sleep apnea electric turn-over bed: mainly composed of blood oxygen saturation monitoring components and electric turn-over bed.By monitoring the changes of blood oxygen saturation value of patients during sleep and transmitting the changes to the electric turning bed, the electric turning bed performs turning action to enable the sleeper to sleep in the lateral position.It can be used to help improve hypoxemia during sleep of patients, and has preventive effect on sudden asphyxia death.Classification code: 07-09.
57. Hemorrhoidal Artery Ultrasonic Positioning and Auxiliary Ligation Suspension System: Consists of Ultrasonic Host, Probe, Bluetooth Speaker and Sleeve.When in use, the probe is placed in the rectum, and the product emits and receives pulse waves and converts the pulse waves into sound signals to judge the position of rectal hemorrhoid artery.After positioning the rectal hemorrhoid artery, the doctor performs operations such as ligation of the rectal hemorrhoid artery and suspension of the prolapsed hemorrhoid body in the reserved window of the sleeve and probe housing.It is used for positioning rectal hemorrhoid artery in operation, assisting ligation of hemorrhoid artery in rectum and suspension of prolapse nevus.Classification code: 01-00.
58. Cardiopulmonary Resuscitation Chest Pressing Frequency Pressure Gauge: It mainly consists of pressure sensor, display screen and buzzer.When in use, the equipment is laid flat on the chest of the rescued person to serve as a hand pad for chest compression, and then cardiopulmonary resuscitation is carried out for chest compression.It is used to display and prompt the pressing frequency and pressing pressure during cardiopulmonary resuscitation (CPR) extrathoracic first aid, and to assist in guiding CPR first aid.Classification code: 08-03.
59. Jaundice detection equipment: consists of cloud computing software, mobile phone processing software and special color comparison cards.The colorimetric card is placed on the skin of the newborn, and the smart phone colorimetric card is used to take photos. After the photos are taken, the mobile phone processing software installed on the smart phone is used to upload the captured images to the cloud server, and the bilirubin value is calculated through the calculation software.Used for noninvasive detection of neonatal jaundice.Classification code: 07-03.
60. Wearable gait monitoring analyzer: It consists of motion acquisition sensors and monitoring and analysis software.The patient wears the device to walk naturally at the waist, and the sensor collects acceleration data of the human body and sends the acceleration data to a smart phone equipped with monitoring and analysis software.It is used for monitoring gait parameters and balance functions such as human gait rhythm, gait symmetry and number of steps, and the monitoring results are used for auxiliary diagnosis of diseases such as dyskinesia, sports injury and the like.Classification code: 07-09.
61. Eye Moxibustion Instrument: It mainly consists of moxibustion column combustion device, sliding platform, temperature control element and limit sensor. The product composition does not contain moxibustion column.The patient's eyes face the moxibustion application window, and the ignited moxibustion column is placed in the equipment, which simulates the manipulations of traditional Chinese medicine technicians for moxibustion treatment, wherein the temperature control element is used for controlling the moxibustion temperature.It can be used for relieving vision fatigue and vision decline.Classification code: 20-02.
62. Electrolytic therapeutic instrument: it consists of main machine, control handle, grounding cushion, disposable probe and anoscope.When in use, the probe contacts the bottom of hemorrhoids and electrolyzes water in hemorrhoid blood vessels by outputting direct current, resulting in protein denaturation, atrophy of hemorrhoids and absorption by human bodies.Can be used for treating internal hemorrhoid patients and hemorrhoid recurrence patients.Classification code: 09-01.
63. Transcranial Direct Current Stimulator: It is mainly composed of main machine, electrode wire, electrode sheet and electrode cap.When in use, the electrode sheet is attached to the corresponding part of the scalp outside the patient's brain and fixed with an electrode cap.Transcranial electrical stimulation is performed by direct current generated by the equipment.It is used in the field of neurological rehabilitation to assist in the treatment of limb movement disorders, cognitive disorders (autism), aphasia, dysphagia, Parkinson's disease, senile dementia and other diseases.Classification code: 09-01.
64. Penile clamp: it consists of negative pressure ball system, glans penis connector, suction cover buckle, adjusting rod sleeve and stretching frame base.The glans penis connector is sucked into the penis through a negative pressure ball system, and then the penis is clamped or fixed by using a suction cover buckle, an adjusting rod sleeve and a stretching frame base.It is used to clamp and fix penis during bladder surgery in urological anorectal surgery and shock wave therapy, and has no therapeutic effect.Classification code: 01-00.
65. Medical image transmission and storage software: software products.The product stores, transmits and uploads electronic films, reports and DICOM medical image data of medical institutions to a cloud server, and users can obtain and view the image data.It is used for the storage, transmission and management of image data by medical institutions for browsing, diagnosis, referral and remote consultation.Classification code: 21-02.
66. Blood sugar data management software: software products.Connect with blood glucose meter, and users upload blood glucose data and view reports.It is used to assist diabetic patients and medical staff to view, analyze and evaluate blood glucose data of patients, and to assist professional medical staff to diagnose and treat diabetes.Classification code: 21-03.
67. Brain state measuring instrument: It consists of data acquisition terminal, EEG sensor, computer and measuring software.Through non-invasive acquisition of brain wave signals, characteristic indexes reflecting changes in brain functional states are obtained.It can be used to measure the brain state of people with anxiety, depression, insomnia, sedation and pain, and assist in the diagnosis of related diseases.Classification code: 07-03.
68. Laser therapy protection/anti-scattering patch: composed of double-layer silica gel film and light transparent agent.The composition contains no pharmaceutical ingredients.Use on the skin surface of the treatment area.During skin laser treatment, particles and liquid generated during treatment are shielded and light scattering is reduced.Classification code: 09-00.
69. Disposable radiation protection gloves for interventional therapy: made of natural rubber latex and radiation protection material (effective component is bismuth trioxide).It is used to protect human body during radiotherapy and diagnosis.Classification code: 06-06.
70. Custom particle implantation surgical template: made of resin material through 3D printing.According to the doctor's plan, the puncture needle was made during 3D printing.When in use, it covers the skin of the patient. During the operation, through the positioning and orientation of the product, the target is guided to be positioned and punctured, and the puncture needle is assisted to push the particles to the pre-planned tumor part.Classification code: 05-04.
71. High-frequency surgical electrode: it consists of electric connecting wire, impedance cable, tuning conversion module, handle and monopolar surgical electrode.The product and the output circuit of the high-frequency host together form a high-frequency power transmission loop, and the high-frequency electromagnetic field energy is transmitted to the front end of the monopolar surgical electrode through an impedance matching mode, so that surgical treatments such as vaporization cutting, ablation, coagulation hemostasis and the like of human tissues are realized by utilizing the biological effect of the electromagnetic field.Classification code: 01-03.
72. Disposable high-frequency surgical electrode: mainly composed of electrode head, functional tube, handle, high-frequency connecting wire, argon hose and argon plug.Used in conjunction with high-frequency surgical equipment, the high-frequency host outputs high-frequency current, which acts on human tissues through the product.At the same time, the external argon controller ensures that argon inert gas flows around the product action site.It is used for electrosurgical cutting and coagulation of target tissues under argon enhancement, and reduces tissue smog and carbonization formation.Classification code: 01-03.
73. Surgical power system: mainly composed of main machine, power handle, lighting rod, cable, light guide beam and negative pressure barrel.In the resection of superficial varicose veins of lower limbs, the power handle is controlled by the host computer in cooperation with external surgical tools to provide power for the resection and collection of human tissues during the surgery.Classification code: 01-10.
74. Electric instrument clamp: mainly composed of instrument clamp beak, endoscope clamp beak, support bracket system, operating bed guide rail fixing clamp and mobile power supply.It is used to clamp, support, fix and move medical instruments outside the body during surgery.It is not used to clamp instruments for operations such as surgery.Classification code: 01-00.
75. Craniocerebral puncture introducer: mainly composed of graduated bow frame, moving slide block and fixing screw.Used for positioning and guiding puncture under CT imaging system.Passive products.Classification code: 06-05.
76. Hot and cold water spray gun: mainly composed of main engine, water tank (including water pipe) and hose.The equipment sprays warm and cold water to the eardrum of the patient's ear canal, and controls the water delivery time and water temperature to stimulate the patient to produce nystagmus.Doctors detect vestibular function in patients with dizziness or imbalance through nystagmus.Classification code: 07-00.
77. Cold and hot gas spray gun: mainly composed of main engine, disposable earmuff and hose.The equipment sprays warm and cold air to the eardrum of the patient's ear canal, and controls the air supply time and air flow temperature to stimulate the patient to produce nystagmus.Doctors detect vestibular function in patients with dizziness or imbalance through nystagmus.Classification code: 07-00.
78. Human body cooler: It is composed of heat absorbing aluminum tube, heat dissipating aluminum tube and heat conducting medium, which is refrigerant and contains no medicine.When in use, the device is placed on the body surface parts such as armpits, leg sockets, palms and the like, the heat in the body of a patient is absorbed through a heat absorption tube, the heat absorbed by the heat absorption tube is transferred to a heat dissipation part by utilizing a natural circulation working principle, and the heat dissipation part emits the heat into the atmosphere.Used for physical cooling of fever patients.Classification code: 09-02.
79. Children's isolation sickbed: it consists of children's sickbed, sterilization and filtration unit, ventilation pipe and control system.The equipment sucks the air exhaled by the patient on the sickbed and enters the sterilization filter unit to discharge the treated air through the air outlet, thus avoiding cross infection.It is applicable to medical or inspection and quarantine units that need isolation of respiratory infectious diseases.Classification code: 15-03.
80. Monitoring information management software: software products.This software collects and processes the data of clinical equipment such as monitors, ventilators and infusion pumps in ICU and the data of PACS and other systems in hospital.It is used for collection, storage, processing and centralized real-time display of medical data.This software does not have the function of guiding drug dosage and does not give advice on diagnosis/treatment.Classification code: 21-03.
81. Urine analysis software: software products.It consists of a urine analysis and detection module, a detection file module, an information module and a personal center module.The software is installed on the smart phone and is matched with a specific urine analysis test paper. The camera of the smart phone is used to scan the color change generated by the reaction between the reagent area on the urine analysis test paper and the components in the urine to determine the content of biochemical components in the urine.It is used for qualitative or semi-quantitative detection of biochemical components of urine (such as glucose, bilirubin, ketone body, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocyte, ascorbic acid, creatinine, calcium, microalbumin, etc.).Classification code: 21-05.
82. Urine analysis and testing software: software products.The software is installed on the smart phone, and is matched with specific urine analysis test paper. After the smart phone is used to take photos of the test paper with urine samples, the results of the smear are analyzed.Used for qualitative analysis and detection of leukocyte, nitrite, protein, pH value and other indicators of urine samples.It is suggested that the management of Class II medical devices be followed.Classification code: 21-05.
83. Remote ECG monitor: It mainly consists of ECG electrodes, digital-to-analog converter, microprocessor and Bluetooth transceiver.The instrument detects ECG data by connecting the user's finger or chest.After ECG signals are collected, the data are transmitted to the smart phone and uploaded to the background server for analysis, storage and report.It is used for self-measurement of electrocardiogram by users in the home environment, and displays and transmits the acquired electrocardiogram data to professional medical personnel through communication equipment connected with a remote server.Classification code: 07-03.
84. Ultra-low-frequency transcranial magnetic stimulator: it mainly consists of main machine, therapeutic head (including coil), electric push rod and control circuit.The equipment generates ultra-low frequency signals, drives a stimulation coil to generate an induction magnetic field to stimulate the brain, reaches deep tissues in the brain through the skull, generates ultra-low frequency induction current in the brain, regulates the functions of neurotransmitters such as GABA, Glu, 5-HT, ACh, NE, DA and the like, and balances the functions of neurotransmitters in the brain.Used for adjuvant treatment of insomnia.Classification code: 09-05.
85. Laryngoscope: Consists of laryngoscope, support frame and adapter.All parts enter the human throat through mechanical connection for examination and treatment of laryngeal diseases.Can be connected with a ventilator for ventilation.Classification code: 08-05.
86. Body temperature probe: composed of sensor plug, cable and temperature sensing end.It is divided into body surface type and intracavitary type, contacting the underarm and rectum/esophagus of the patient respectively.In the medical environment such as operating room, emergency room, ICU, etc., it is used in conjunction with patient monitoring equipment to measure the temperature in human body cavity and body surface.Classification code: 07-10.
87. Auxiliary sleep glasses: consisting of glasses, ear rests and charging equipment.After users wear it, they can adjust the secretion of melatonin and cortisol, reduce the excitement at night and improve the sleep quality through the illumination effect generated by illuminating the retina.It can be used for adjuvant treatment of insomnia.Classification code: 09-00.
88. Electric diagnosis and treatment chair: mainly composed of base, chair seat, backrest, headrest, foot switch, hydraulic engine, driving wheel, etc.Provide posture support for patients in otolaryngology clinic.Classification code: 15-02.
89. Breast ultrasound tomography system: consists of a scanning bed and an image processing workstation.The principle of ultrasonic tomography is applied to scan and image human breast tissue for clinical diagnosis.Classification code: 06-07.
90. Fluoroscope: Consists of an optical imaging system and an illumination system.The working principle of the optical imaging system is that the inverted image formed by the object to be observed through the objective lens is transmitted to the eyepiece in the form of an inverted image through the imaging system. After being amplified by the eyepiece, the medical imaging system and the monitor connected through the eyepiece end are observed by the doctor.The principle of the lighting system is that the light from the cold light source is transmitted to the external mirror through the optical fiber to illuminate the object to be observed.The product is used for in vitro visualization of surgical field of vision during open surgical diagnosis and treatment.The product contains a filter which can pass through fluorescence spectrum and is used for observing fluorescent luminescent substances.The product itself does not contain fluorescent luminescent substances.Classification code: 06-13.
91. Infant cranial image acquisition system: consists of nylon cloth cover, paper marker and application program.After collecting the graphic information of the fixed-point part of the head, the data calculated by computer software can be used to assist doctors and technicians to analyze the craniofacial development of infants and provide basis for customizing orthopedic helmet products.Classification code: 06-00.
92. Olfactory pen: It consists of an aluminum pen holder and a polypropylene resin cap. The pen holder contains PET fibers with different odorants.When in use, let the subject smell the smell of the pen.It is used for auxiliary diagnosis of olfactory function, distinguishing patients with olfactory dysfunction and evaluating olfactory function.Classification code: 07-00.
93. Prostate fluid assisted extraction rod: composed of silica gel, medical plastic tube and eccentric wheel motor.When in use, the product is inserted through the anus to reach the prostate part, and the eccentric wheel is driven by the motor to rotate at a constant speed to press the prostate part and stimulate the production of prostate liquid.It is used to assist the extraction of prostate fluid from patients, and the extracted prostate fluid is used for the auxiliary diagnosis of prostate diseases.Classification code: 07-00.
94. Low and medium frequency therapeutic equipment: it consists of main machine, output cable, power cord, electrode plate, etc.The electrode patch is attached to the designated part of the human body, and the epidermis is stimulated by pulse current, and the user is prompted to cooperate with the pulse frequency to rhythmically contract and relax the vaginal muscle, so as to achieve the purpose of assisting in exercising the vaginal muscle.Classification code: 09-01.
95. Medical body surface warming blanket: composed of polypropylene non-woven fabric and polyethylene film.Can cooperate with various air heating hosts to heat and inflate, evenly distribute high convection air around the patient's body to form a warm local environment, so as to improve the body surface temperature of the patient.It is used for adjuvant treatment of patients with hypothermia.Classification code: 09-02.
96. Light-induced insomnia therapeutic instrument: consists of bed body, hood (including LED light source), console and control software.Visible light with a specific frequency acts on the closed human eyes, so that the brain generates electrical activity of neurons with synchronous frequency, induces the cerebral cortex from a tense and excited state to a relaxed state, acts on the back of the human body with low-frequency vibration, and can play music and/or voice.Can be used for treating insomnia caused by non-organic reasons, and is not used for treating insomnia caused by anxiety and depression.Classification code: 09-03.
97. Nail Tension Patch: Made of Epoxy Resin by Stamping.The product is attached to the nail to generate upward rebound pulling force and change the shape and bending degree of the nail.The nail embedded in the human body is pulled out to restore the normal bending degree of the nail, and is used for preventing and treating ingrown nail.Classification code: 09-04.
98. Far-infrared bedsore prevention mattress: it is composed of surface cloth layer (plain cloth), inner layer (containing far-infrared ore) and surface cloth (superfine fiber and superfine wool).The product contains a hollow inflatable structure, which can increase the contact area between the patient's body and the pad and reduce the local pressure of the body.The infrared ray emitted by far infrared ore can raise the temperature of subcutaneous deep skin, expand microvessels, promote blood circulation and avoid tissue nutrient deficiency, thus achieving the purpose of preventing and relieving pressure ulcers.Can be used for preventing and relieving pressure sore for postoperative or long-term sitting and lying patients.Classification code: 15-06.
99. Leg support: composed of support and cushion.The product is manually adjusted and assisted by gas spring.When in use, the cushion covers the foot of the patient and is fixed on the bracket.Used for fixing and supporting the legs of adult or child patients before, during and after surgery.Classification code: 15-04.
100. Pneumonia strain identification instrument: composed of host computer (sensor module), software and power adapter.It is used to identify and calculate the infection rate of pneumonia bacteria in the gas breathed by intubated patients using breathing machine, and provides an auxiliary reference for doctors to monitor the condition of patients.Classification code: 22-06.
101. Single cell image analysis automatic sorter: composed of slide placement table, optical imaging system, image acquisition system, electric object scanning platform, image analysis software, computer system and cell transfer.Cells on the slide are presented as images by photographic scanning, which is clinically used to observe, screen and analyze microscopic images of individual cells in the sample.Classification code: 22-07.
102. glial fibrillary acidic protein (GFAP) determination kit (magnetic particle chemiluminescence method): it consists of glial fibrillary acidic protein detection reagent strip (including antibody reagent, enzyme labeled reagent, magnetic separation reagent, substrate liquid and washing liquid), quality control product, calibration product, drying agent and instructions.The method is used for quantitatively detecting the content of glial fibrillary acidic protein in a human serum sample in vitro.Clinically, it is mainly used for auxiliary diagnosis of traumatic brain injury.Classification code: 6840.
103. Human 14-3-3 eta protein determination kit (photo-stimulated chemiluminescence method): consists of reagent 1 (luminescent particles coated with anti-14-3-3 eta protein antibody), reagent 2 (biotin-labeled anti-14-3-3 eta protein antibody), calibrators (recombinant antigen 14-3-3 eta protein), low-level controls and high-level controls.Used in LiCA 500 series automatic photoluminescence analysis system for quantitative determination of 14-3-3 eta protein in human serum.It is clinically used for auxiliary diagnosis of rheumatoid arthritis.Classification code: 6840.
104. Paclitaxel assay kit (latex immunoturbidimetry): consists of reagent 1 (paclitaxel conjugated drug) and reagent 2 (paclitaxel antibody modified particles).Which is use for quantitatively detecting that concentration of paclitaxel in a human plasma sample.Clinically, other clinical information can be combined to adjust the dosage of drugs, improve the curative effect and reduce adverse reactions.Classification code: 6840.
105. imatinib assay kit (latex immunoturbidimetry): consists of reagent 1 (disodium hydrogen phosphate citrate buffer), reagent 2 (imatinib antibody modified particles), calibrator and quality control.Which is use for quantitatively detecting that concentration of imatinib in a human plasma sample.Clinically combined with other clinical information, it can be used to adjust the dosage in time, improve the chemotherapy effect and reduce adverse reactions.Classification code: 6840.
106.5-fluorouracil assay kit (latex immunoturbidimetry): consists of reagent 1 (5-fluorouracil conjugated drug) and reagent 2 (5-fluorouracil antibody modified particles).Which is used for quantitatively detecting the concentration of 5-fluorouracil in a human plasma sample.Clinically, combined with other clinical information, it can provide assistant function of dose management for doctors.Classification code: 6840.
107. Docetaxel assay kit (latex immunoturbidimetry): consists of reagent 1 (docetaxel conjugated drug) and reagent 2 (docetaxel antibody modified particles).Used for in vitro quantitative detection of docetaxel (DTX) drug concentration in human plasma samples. Clinically, dose management is carried out in combination with other clinical information to improve curative effect and reduce adverse reactions.Classification code: 6840.
108. Soluble CD14 subtype determination kit (chemiluminescent immunoassay): It consists of alkaline phosphatase labeled anti-soluble CD14 subtype polyclonal antibody, magnetic particles coated with anti-soluble CD14 subtype monoclonal antibody, chemiluminescent substrate, sample dilution buffer and sample washing buffer.The method is used for quantitatively detecting the concentration of soluble CD14 subtypes in human whole blood or plasma in vitro.Clinically, it is used for the diagnosis and prognosis evaluation of sepsis, monitoring the disease process and the response to sepsis treatment interventions.Classification code: 6840.
109. Human asialoglycoprotein receptor H2 subunit (sH2a) quantitative detection kit (enzyme linked immunosorbent assay): consists of reaction plate, enzyme labeled antibody, standard substance, diluent, TMB substrate solution A, TMB substrate solution B, termination liquid and quality control substance.It is used for quantitative detection of asialoglycoprotein receptor H2 subunit (sH2a) in soluble form in human serum samples.Clinically used for auxiliary diagnosis of liver injury diseases such as fatty liver, alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, viral hepatitis, liver cirrhosis and the like.Classification code: 6840.
110. Special quality control for antibody IgG detection: consists of quality control membrane strip coated with quality control antigen, test control and target value reference table.The method is used for quality control of in vitro detection of an immunoblotting method and an Oumeng blotting method detection system.Classification code: 6840.
111. Rabbit monoclonal negative control antibody: composed of rabbit monoclonal antibody.Quality control for nonspecific binding of rabbit immunoglobulin in formalin-fixed paraffin-embedded tissue sections.Classification code: 6840.
112. Cell glucose metabolism detection kit: consists of fluorescent dye I, fluorescent dye II, fluorescent dye III, culture medium, buffer solution and lysis solution.It is used for culturing nucleated cells in body fluid samples to distinguish the aerobic glycolysis level of cells.It is clinically used for auxiliary diagnosis of inflammation and immune diseases.Classification code: 6840.
113. Pre-eclampsia detection kit (spot diffusion method): mainly composed of detection card, staining result example, dropper and urine cup.Misfolded proteins exist in the urine of pregnant women with preeclampsia. The misfolded proteins can specifically bind with staining solution, showing a significantly different diffusion mode from normal proteins on cellulose membrane.Clinically, the diagnosis of preeclampsia is assisted by qualitative detection of misfolded proteins in urine of pregnant women.Classification code: 6840.
114. paliperidone detection kit (latex immunoturbidimetry): consists of reagent 1(R1: paliperidone conjugated drug), reagent 2(R2: paliperidone antibody modified particles), calibrator and quality control.Clinically, the dosage of the patient is controlled by measuring the concentration of paliperidone in a human serum sample.Classification code: 6840.
115. Risperidone detection kit (latex immunoturbidimetry): consists of reagent 1(R1: Risperidone conjugated drug), reagent 2(R2: Risperidone antibody modified particles), calibrators and quality control products.Clinically, the dosage of risperidone is controlled by measuring the concentration of risperidone in human plasma samples.Classification code: 6840.
116. imatinib blood concentration determination kit (liquid chromatography-tandem mass spectrometry): composed of calibrators, quality controls, internal standards, etc.The concentration of imatinib in dried blood spots of human fingertip peripheral blood collection card was quantitatively detected in vitro by liquid chromatography-tandem mass spectrometry, which can provide reference for doctors to control the dosage of patients clinically.Classification code: 6840.
117. Uric acid metabolite detection kit (colorimetric method): it consists of buffer solution, enzyme substance, probe (chromogenic solution) and standard substance.Through the qualitative detection of human urine, whether the metabolism of human uric acid (hypoxanthine, xanthine) derivatives is normal is detected qualitatively, which is clinically used for auxiliary diagnosis of metabolic syndrome.Classification code: 6840.
118. Eosinophil cationic protease labeled specific antibody: mainly composed of-galactosidase-anti-IgE (mouse monoclonal antibody) and sodium azide.It is used together with eosinophil cationic protein detection reagent (fluorescence immunoassay). Clinically, eosinophil cationic protein in human serum is quantitatively detected in vitro, which is used to assist diagnosis of eosinophil mediated inflammatory diseases, such as asthma.Classification code: 6840.
119. Pancreatic elastase 1(E1) detection kit (enzyme linked immunosorbent assay): consists of enzyme-labeled plate, sample/washing buffer solution, standard solution 1-4, control solution 1, control solution 2, biotin-streptavidin-peroxidase (POD)-labeled anti-E1 monoclonal antibody, substrate solution and termination solution.Quantitative determination of E1 in human stool samples by enzyme linked immunosorbent assay.Clinically used to diagnose or exclude pancreatic diseases related to gastrointestinal symptoms.Classification code: 6840.
120. guanidinoacetic acid and creatine assay kit (tandem mass spectrometry): it consists of internal standard, high-level quality control, low-level quality control, quality analysis report of quality control and quality analysis report of internal standard.Through tandem mass spectrometry (MS/MS) technology, the concentrations of guanidyl acetic acid (GAA) and creatine (CRE) in filter paper dried blood tablets are determined, which is suitable for abnormal detection of guanidyl acetic acid and creatine levels of people aged 0-15 years (including newborns) and over 15 years old, and is clinically used for auxiliary diagnosis of defects of guanidyl acetic acid methyltransferase.Classification code: 6840.
121. Glucose calibration solution: composed of glucose, bactericide, stabilizer and phosphate diluent.Used in conjunction with glucose detector, it is mainly used for calibration of biosensor glucose detector.Classification code: 6840.
122. Sperm Chromatin Structure Test Kit: Consists of Reagent A (hydrochloric acid, Tween-20, PBS) and Reagent B (acridine orange, water).Used for staining human sperm chromatin, judging the level of chromatin DNA breakage and calculating the proportion of sperm with DNA breakage. At the same time, the proportion of immature sperm can be analyzed by the degree of chromatin binding to protein.Classification code: 6840.