1. Products managed by three types of medical devices (69 products);
2. Products managed according to Class II medical devices (122);
Three. Products managed according to Class I medical devices (219);
Iv. Not as a separate medical device management product (19);
Five, according to the combination management of medical device products (22);
6. Products not managed as medical devices (110);
Seven, depending on the specific situation of the product (12).
Description:
1. The product classification result is based on the information provided by the applicant, which does not represent the recognition of the safety and effectiveness of its products, but only serves 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 no "classification code" corresponding to the first product category in the Catalogue of Medical Devices. Take "00" as an example, and the classification code of "Plasma Therapeutic Apparatus" is 09-00.
The products involved in in in vitro diagnosis are as follows:
I. Products managed according to Category III medical devices (34 products)
1. Real-time vacuum automatic blood sampler: It consists of a mobile tube changing unit, a puncture plug mixing unit, a needle feeding unit, a vacuumizing unit, a blood collection tube holder, an optical quantitative detection unit, an electronic control unit and an extravasation detection unit. Blood is collected from the human body by the negative pressure generated by the negative pressure pump in the machine, and the amount of blood collected is quantitatively detected by the optical detection system. Immediately after blood collection, the blood collection tube is rotated, so that the blood is evenly mixed with the additives in the tube, and finally a blood sample meeting the requirements is obtained. Clinically, it is used to collect venous blood of patients in hospital outpatient department and blood collection center. Classification code: 22- 1 1.
2. Gene sequencing library kit: It consists of library amplification reaction solution, buffer solution, DNA ligase and sequence linker. It is used to process the target sequence of human genome DNA extracted from peripheral blood or paraffin-embedded tissues and the resulting sample library. It is used together with Illumina second-generation sequencer and sequencing reaction universal kit. No human genome sequencing or de novo sequencing. Classification code: 6840.
3. Ubiquitin carboxy-terminal hydrolase-1(UCH-L 1) detection kit (magnetic particle chemiluminescence method): it consists of ubiquitin carboxy-terminal hydrolase-1(UCH-L 1) detection reagent strip, quality control product, calibrator and desiccant. It can be used to determine the content of UCH-L 1 in human serum samples, monitor the occurrence and development of neurodegenerative diseases and tumors, and assist in the diagnosis of brain trauma. Classification code: 6840.
4. T.V. Secreted protein detection kit (colloidal gold method): composed of T.V. Secreted protein detection test strip/test card and sample buffer. Used for qualitative detection of trichomonas vaginalis secreted protein in female vaginal secretions and urine samples, and clinically used for auxiliary diagnosis of trichomonas vaginalis infection in female vaginitis. Classification code: 6840.
5. Candida albicans secretory protein detection kit (colloidal gold method: composed of test strips/cards for detecting Candida albicans secretory protein and sample buffer. It can be used to qualitatively detect the secretory protein of Candida albicans in female vaginal secretion samples and urine samples, and can be used as an auxiliary diagnosis of female candidal vaginitis infection in clinic. Classification code: 6840.
6. Detection kit for Helicobacter pylori (H.P.) secreted protein (colloidal gold method): It consists of test strips/cards for detecting Helicobacter pylori (H.P.) secreted protein and sample buffer. It can be used for qualitative detection of Helicobacter pylori secreted protein in stool samples, and clinically used for auxiliary diagnosis of gastritis, digestive tract ulcer, duodenal ulcer and other inflammations. Classification code: 6840.
7. Detection kit for secreted protein of Mycobacterium tuberculosis (colloidal gold method): It consists of test strips/cards for detecting secreted protein of Mycobacterium tuberculosis and sample buffer. It is used for qualitative detection of tuberculosis secretion protein in tuberculosis culture medium and sputum, and is used for auxiliary diagnosis of tuberculosis in clinic. Classification code: 6840.
8. Human peripheral blood leukocyte removal kit (negative immune magnetic particle method): It consists of blood pretreatment solution A, blood pretreatment solution B, separation solution and magnetic particle suspension. It is used to remove white blood cells from whole blood in vitro for downstream analysis. Classification code: 6840.
9. Detection kit for IL-1β, IL-6, IL-8, IL- 10 and TNF-α (flow cytometry): composed of capture microsphere mixture, quantitative standard, fluorescence detection reagent, calibration microsphere, calibration solution A, calibration solution B, sample diluent and microsphere buffer. Used to detect the contents of IL- 1β, IL-6, IL-8, IL- 10 and TNF-α protein in serum or plasma. Clinically, it is used for auxiliary diagnosis, medication and prognosis intervention of diseases. Classification code: 6840.
10.IL-2, IL-4, IL- 17, IFN-γ determination kit (flow cytometry method): It consists of capture microsphere mixed solution, quantitative standard, fluorescence detection reagent, calibration microsphere, calibration solution A, calibration solution B, sample diluent and microsphere buffer. Used to detect the contents of IL-2, IL-4, IL- 17 and IFN-γ protein in serum or plasma. Clinically, it is used for auxiliary diagnosis, medication and prognosis intervention of diseases. Classification code: 6840.
1 1.HER2 three-in-one pathological quality control tablet: it consists of three human breast cancer cell line samples fixed in formalin and embedded in paraffin from different sources. In a specific detection system, the quality control chip 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.
12.HER-2 four-in-one pathological quality control tablet: it consists of four human breast cancer cell lines fixed in formalin and embedded in paraffin from different sources. It is used to monitor the immunohistochemical staining performance of anti-c-erbB-2/HER-2 antibody. Classification code: 6840.
13.HER2 double staining in situ hybridization three-in-one pathological quality control tablet: it consists of three tumor cell lines fixed in formalin and embedded in paraffin from different sources. On the special detection system, it is used for quality control of clinical detection experiments together with specific probes. Classification code: 6840.
14. Dinitrobenzene (DNP) antibody reagent: It consists of rabbit anti-DNP monoclonal antibody and buffer containing carrier protein and preservative. Clinically, it is used in conjunction with HER2/CEN 17 double probe detection kit to detect DNP-labeled HER2 DNA probe and chromosome 17 probe. Classification code: 6840.
15. Five-way chemokine detection kit (flow cytometry method): composed 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, etc. Quantitative standard (human recombinant protein freeze-dried powder), fluorescence detection reagent (PE labeled microsphere for antibody detection), 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, sodium chloride, fetal bovine serum, preservative). Combined with flow cytometry, the contents of five chemokines (CXCL8/IL-8, CCL5/RANTES, CXCL9/MIG, CCL2/MCP- 1, cxcl1IP-10) were detected. Clinically used to evaluate the immune function of the body. Classification code: 6840.
16. Gene sequencing library kit (transposase method): It consists of reagent 1 (fragment buffer, fragment enzyme, amplification buffer, amplification enzyme, eluent), reagent 2 (tag primer) and reagent 3 (magnetic beads). It is used together with general reagents for gene sequencing and Illumina gene sequencing system to process human genome DNA, single cell amplification products, cDNA and build libraries. Classification code: 6840.
17. sequencing kit for gene sequencing: composed of dNTP, reactive enzyme, sequencing primer, buffer, etc. It is used together with an ion torrent sequencing platform combining a gene sequencing library kit, a gene sequencing template kit and a gene sequencing chip to process the human genome DNA extracted from a tissue sample and the target sequence of the sample library generated thereby. Not the entire human genome or de novo sequencing. Classification code: 6840.
18.AML/MDS probe chip (in situ hybridization method): It consists of AML/MDS probe chip, sample slice and chip hybridization buffer. Qualitative detection of P53, PML/RARA, KMT2A, AML 1/ETO, 5q3 1(EGR 1/TERT), CBFB/MYH 1 1, 7Q3/KLOC-0. It is clinically used for the auxiliary diagnosis of leukemia. Classification code: 6840.
19. full probe chip (in-situ hybridization method): it consists of full probe chip, sample chip and chip hybridization buffer. Through the hybridization test, whether there are abnormalities in the MYC, ETV6/AML 1, IGH, BCR/ABL 1(DF), E2A, CDKN2A/CSP 17, KMT2A, 4/ 10 genes in the sample is qualitatively detected. It is used to guide the use of tyrosine kinase inhibitors in clinic. Classification code: 6840.
20.MPN probe chip (in situ hybridization method): It consists of MPN probe chip, sample chip and chip hybridization buffer. Through hybridization test, whether there are abnormalities in FGFR 1, PDGFRB, PDGFRA, BCR/ABL 1(DF) genes in the samples is qualitatively detected. It is used to guide the use of tyrosine kinase inhibitors in clinic. Classification code: 6840.
2 1.ph-like full probe chip (in-situ hybridization method): it consists of ph-like full probe chip, sample slice and chip hybridization buffer. Through the hybridization test, whether there are abnormalities in CRLF2, PDGFRB, ABL/KOC-0/,CSF/KOC-0/R, BCR/ABL/KOC-0/(DF), ABL2, JAK2 and EPOR genes in the sample is qualitatively detected. It is clinically used for the auxiliary diagnosis of Ph-like acute lymphoblastic leukemia. Classification code: 6840.
22. Automatic blood bank system: It consists of sampler, conveyor, punching mechanism, incubator, centrifuge, reader, barcode 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 and positive) and storage. Classification code: 22-0 1.
23. Neutral detection card (microcolumn gel method): It is mainly composed of 8 microporous tubes, dextran polymer and preservative. Agglutinated red blood cells are separated from non-agglutinated red blood cells by the reaction of antigen and antibody and the action of molecular sieve. It is clinically used to detect the agglutination reaction of red blood cells. Classification code: 6840.
24. Gene sequencing library kit (DNA fragmentation method): It consists of terminal repair mixture, terminal repair buffer, T4 DNA ligase, T4 DNA ligase buffer, PCR mixture, linker suitable for Illumina sequencing platform, universal primer and sequence tag primer 1- 12. Construction of DNA sequencing library of Illumina second-generation sequencing platform. Classification code: 6840.
25. 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 mixed solution 1-96, DNA purification magnetic beads, etc. The target gene is amplified by multiplex PCR technology, and then the amplified product is cut by primer digestive enzyme to form a blunt end which can be connected with the specific linker mixture. Under the action of the connection buffer and DNA ligase, a library which can be used for ion torrent sequencing platform is formed. Classification code: 6840.
26. Epidermal growth factor receptor ⅴ ⅲ antibody reagent (immunohistochemical method): composed of epidermal growth factor receptor ⅴ ⅲ antibody and buffer. It can be used for in vitro qualitative detection of EGFR vⅲ protein in human tissues fixed with 10% neutral buffer formalin and embedded in paraffin, and it can be used as a new target for diagnosis and treatment of various tumors (such as breast cancer, liver cancer and colon cancer) in clinic. Classification code: 6840.
27. tyrosine kinase receptor (ROS 1) antibody reagent (immunohistochemical method): it consists of tyrosine kinase receptor (ROS 1) antibody reagent. It has clinical diagnostic value for non-small cell lung cancer or can be used to screen lung cancer with ROS 1 gene rearrangement. Classification code: 6840.
28. Mycobacterium tuberculosis secretory protein (Ag85B) (immunohistochemical method): It consists of antibody reagent of Mycobacterium tuberculosis secretory protein (Ag85B). Immunohistochemical staining on the basis of routine staining has clinical value for pathological diagnosis of tuberculosis. Classification code: 6840.
29. Epidermal growth factor receptor L858R(EGFR L858R) mutant protein antibody reagent (immunohistochemical method): composed of epidermal growth factor receptor L858R mutant protein antibody and buffer. It can be used for qualitative detection of EGFR L858R protein in human tissues fixed with 10% neutral buffer formalin and embedded in paraffin, and has clinical diagnostic value for non-small cell lung cancer. Classification code: 6840.
30.MDS probe chip (in situ hybridization method): It consists of MDS probe chip, sample chip and chip hybridization buffer. 5q33(CSF 1R/TERT), D20S 108, 5q3 1(EGR 1/TERT), X/Y, 7q31(. It is clinically used for the auxiliary diagnosis of myelodysplastic syndrome. Classification code: 6840.
3 1.IFN-γ/IL-4 detection reagent (flow cytometry): It consists of phosphate buffer (PBS) and fluorescent FITC/PE labeled IFN-γ/IL-4 monoclonal antibody. The IFN-γ and IL-4 in human biological samples were detected by flow cytometry, which was used for the auxiliary diagnosis of chronic lymphocytic leukemia (CLL) and infectious diseases. Classification code: 6840.
32. Library construction and purification kit: It consists of 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. Used for the construction and purification of Illumina second-generation sequencing library. Classification code: 6840.
33. Library preparation kit: It consists of buffer 1, reactive enzyme 1, buffer 2, reactive enzyme 2, linker label, PCR amplification mixture, PCR primer mixture and instructions. Construction of DNA sequencing library on Illumina sequencing platform. Classification code: 6840.
34. Gene sequencing library kit: It consists of PCR mixed solution, universal primer suitable for Illumina sequencing platform and sequence tag primer 1- 12. Through one-step PCR amplification, the DNA library of Illumina second-generation sequencing platform was constructed, and the sequencing information of samples could be obtained according to the index sequence in the amplified primers. Not suitable for human genome sequencing. Classification code: 6840.
Two. Products managed according to Class II medical devices (22 products)
1. Trace element analyzer: composed of host computer and software. Using spectrophotometry, the contents of minerals and heavy metals in the skin are obtained by measuring the measuring points on the palm. Used to detect the contents of minerals and heavy metals in human skin, and assist in screening diseases caused by heavy metal poisoning or mineral imbalance. Classification code: 07-00.
2.GFAP detection kit (magnetic particle chemiluminescence method): It consists of glial fibrillary acidic protein detection reagent strips (including antibody reagent, enzyme-labeled reagent, magnetic separation reagent, substrate solution and washing solution), quality control products, calibrators, desiccants and instructions. It is used to quantitatively detect the content of glial fibrillary acidic protein in human serum samples in vitro. Clinically, it is mainly used for the auxiliary diagnosis of brain trauma. Classification code: 6840.
3. Human 14-3-3 eta protein detection kit (light-stimulated chemiluminescence method): consisting of reagent 1 (luminous particles coated with anti-14-3-3 eta protein antibody) and reagent 2 (biotin-labeled anti-14-3-3) It was used in LiCA 500 series automatic photoinduced chemiluminescence analysis system to quantitatively determine 14-3-3 eta protein in human serum. It is clinically used for the auxiliary diagnosis of rheumatoid arthritis. Classification code: 6840.
4. Paclitaxel detection kit (latex immunoturbidimetry): It consists of reagent 1 (paclitaxel binding drug) and reagent 2 (paclitaxel antibody modified particles). It is used to quantitatively detect the concentration of paclitaxel in human plasma samples. Clinically, the dosage of drugs can be adjusted in combination with other clinical information to improve the curative effect and reduce adverse reactions. Classification code: 6840.
5. Imatinib detection kit (latex immunoturbidimetry): It consists of reagent 1 (disodium hydrogen phosphate citrate buffer), reagent 2 (imatinib antibody modified particles), calibrator and quality control. It is used to quantitatively detect the concentration of imatinib in human plasma samples. Combined with other clinical information, it can be used to adjust dosage in time, improve chemotherapy effect and reduce adverse reactions. Classification code: 6840.
6.5- fluorouracil detection kit (latex immunoturbidimetry): It consists of reagent 1(5- fluorouracil binding drug) and reagent 2(5- fluorouracil antibody modified particles). It is used to quantitatively detect the concentration of 5- fluorouracil in human plasma samples. Combined with other clinical information, it can provide doctors with the auxiliary function of dose management. Classification code: 6840.
7. Docetaxel detection kit (latex immunoturbidimetry): It consists of reagent 1 (Docetaxel binding drug) and reagent 2 (Docetaxel antibody modified particles). It is used to quantitatively detect the drug concentration of docetaxel (DTX) in human plasma samples in vitro, and to manage the dose in combination with other clinical information in order to improve the curative effect and reduce adverse reactions. Classification code: 6840.
8. Soluble CD 14 subtype determination kit (chemiluminescence immunoassay): It consists of anti-soluble CD 14 subtype polyclonal antibody labeled with alkaline phosphatase, magnetic particles coated with anti-soluble CD 14 subtype monoclonal antibody, chemiluminescence substrate, sample dilution buffer and sample washing buffer. It is used to quantitatively detect the concentration of soluble CD 14 subtype in human whole blood or plasma in vitro. Clinically, it is used for the diagnosis and prognosis evaluation of sepsis, monitoring the progress of the disease and the response to the intervention measures of sepsis treatment. Classification code: 6840.
9. Quantitative detection kit for human asialoglycoprotein receptor H2 subunit (sH2a) (enzyme-linked immunosorbent assay): consisting of reaction plate, enzyme-labeled antibody, standard, diluent, TMB substrate solution A, TMB substrate solution B, stop solution and quality control. It is used to quantitatively detect the soluble form of asialoglycoprotein receptor H2 subunit (sH2a) in human serum samples. Clinically, it is used for the auxiliary diagnosis of fatty liver, alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, viral hepatitis, liver cirrhosis and other liver injury diseases. Classification code: 6840.
10. Special quality control product for antibody IgG detection: composed of quality control membrane strip coated with quality control antigen, inspection quality control product and target value reference table. Used for quality control of in vitro detection of western blot and Omron blot detection system. Classification code: 6840.
1 1. Rabbit monoclonal negative quality control antibody: composed of rabbit monoclonal antibody. Quality control of nonspecific binding of rabbit immunoglobulin in paraffin-embedded tissue sections for formalin fixation. Classification code: 6840.
12. Cell glucose metabolism detection kit: It consists of fluorescent dye I, fluorescent dye II, fluorescent dye III, culture medium, buffer and lysate. Used to culture nucleated cells in body fluid samples to distinguish the level of aerobic glycolysis. Clinically, it is used for the auxiliary diagnosis of inflammatory and immune diseases. Classification code: 6840.
13. Pre-eclampsia detection kit (dot diffusion method): mainly composed of detection card, staining result sample, dropper and urine cup. There are misfolded protein in urine of pregnant women with preeclampsia. The misfolded protein can specifically bind to the dye solution, and its diffusion pattern on cellulose membrane is obviously different from that of normal protein. Clinically, the diagnosis of preeclampsia is assisted by qualitative detection of misfolded protein in pregnant women's urine. Classification code: 6840.
14. Paparisperidone detection kit (latex immunoturbidimetry): It consists of reagent 1(R 1: Paparisperidone binding drug), reagent 2(R2: Paparisperidone antibody modified particles), calibrator and quality control. Clinically, the dose of patients is controlled by measuring the concentration of papaverine in human serum samples. Classification code: 6840.
15. Risperidone detection kit (latex immunoturbidimetry): consisting of reagent 1(R 1: risperidone conjugate), reagent 2(R2: risperidone antibody modified particles), calibrator and quality control. The dose of patients is controlled by measuring the concentration of risperidone in human plasma samples. Classification code: 6840.
16. Imatinib plasma concentration determination kit (liquid chromatography-tandem mass spectrometry): composed of calibrator, quality control, internal standard, etc. Liquid chromatography-tandem mass spectrometry was used to quantitatively detect the concentration of imatinib in dried blood spots of human fingertip peripheral blood collection card in vitro, which provided reference for clinicians to control the dosage of patients. Classification code: 6840.
17. uric acid metabolite detection kit (colorimetric method): composed of buffer, enzyme, probe (chromogenic solution) and standard substance. Through the detection of human urine, whether the metabolism of human uric acid (hypoxanthine, xanthine) derivatives is normal is qualitatively detected, which is used for the auxiliary diagnosis of clinical metabolic syndrome. Classification code: 6840.
18. specific antibody labeled with eosinophil cationic protease: mainly composed of? -galactosidase-anti-IgE (mouse monoclonal antibody) and sodium azide. It is used in combination with eosinophil cationic protein detection reagent (fluorescence immunoassay) to quantitatively detect eosinophil cationic protein in human serum in clinic, which is used to assist in the diagnosis of eosinophil-mediated inflammatory diseases, such as asthma. Classification code: 6840.
19. trypsin 1(E 1) detection kit (enzyme-linked immunosorbent assay): composed of enzyme-labeled plate, sample/washing buffer, standard solution 1-4, control solution 1, control solution 2 and biotin-streptavidin affinity. Quantitative determination of E 1 in human feces by enzyme-linked immunosorbent assay. Clinically, it is used to diagnose or exclude pancreatic diseases related to gastrointestinal symptoms. Classification code: 6840.
20. Guanidinoacetic acid and creatine determination kit (tandem mass spectrometry): It consists of internal standard, high quality control, low quality control, quality analysis report of quality control and quality analysis report of internal standard. The concentrations of guanidinoacetic acid (GAA) and creatine (CRE) in filter paper dried blood tablets were determined by tandem mass spectrometry, which is suitable for the detection of abnormal levels of guanidinoacetic acid and creatine in people aged 0- 15 years (including newborns) and 15 years or older, and is used as an auxiliary drug for guanidinomethyltransferase deficiency in clinic. Classification code: 6840.
2 1. glucose calibration solution: composed of glucose, bactericide, stabilizer and phosphate diluent. Used in conjunction with glucose detector, it is mainly used for the calibration of biosensor glucose detector. Classification code: 6840.
22. Sperm chromatin structure detection kit: It consists of reagent A (hydrochloric acid, Tween -20, PBS) and reagent B (acridine orange, water). It can be used for human sperm chromatin staining, judging the degree of chromatin DNA breakage and calculating the proportion of DNA-broken sperm, and also analyzing the proportion of immature sperm by the degree of chromatin binding to protein. Classification code: 6840.