1, Daan Genetics: the main PCR reagent supplier in China
2, Kewa Bio: China's enzyme immunoassay kits large-scale commercialization of the promoter
3, Lidman: high-end route to the biochemical diagnostic reagent suppliers
4, Jiuqiang Bio: pioneered the first IVD enterprises in China to export the technology
5, Wanfu Bio: China's POCT industry leader
6, Direx Medical: medical testing laboratory overall solution provider
7, Meikang Biological POCT industry leader in China
6, Direx Medical: medical testing laboratory total solution provider
7, Mekang Biological: China's biochemical diagnostic field of the most complete varieties of one of the suppliers
8, Sannuo Biological: in the world's leading blood glucose meter camp
9, Kewa Biological: the main supplier of foreign AIDS diagnostic reagents
10, Mike Bio: China's largest clinical in vitro diagnostic products, one of the research and development enterprises11, Kemper Bio: the main provider of nucleic acid molecular diagnostic products
12, Yang Pu medical: the leading domestic blood diagnostic field
13, Bohui Innovation: the leading domestic trace element testing
14, Ribon Instruments: a company focusing on blood cell analysis instruments
15, Fosun Pharmaceuticals: a leading domestic biochemical testing instruments
16, base egg biological: the latest listed companies in the field of POCT in China
17, Aide Bio: a tumor precision medicine molecular diagnostic leader
Expanding Knowledge:
I. Introduction to in vitro diagnostic reagents
The in vitro diagnostic reagents referred to in the Measures for the Administration of Registration of In Vitro Diagnostic Reagents (for Trial Implementation) refers to in vitro diagnostic reagents that are managed according to the management of medical devices, including the in vitro diagnostic reagents that can be used alone or in combination with instruments, apparatuses, equipment, or systems for use in the prevention of disease, diagnosis, therapeutic monitoring, prognostic observation, evaluation of the health state As well as hereditary disease prediction process, for human samples (various body fluids, cells, tissue samples, etc.) for in vitro testing of reagents, kits, calibrators (things), quality control products (things).
Two, in vitro diagnostic reagents classification
Based on the degree of risk of the product, in vitro diagnostic reagents are divided into the third category, the second category, the first category of products.
(A) the third category of products:
1. reagents related to the detection of pathogenic pathogens antigens, antibodies and nucleic acids;
2. reagents related to blood type, tissue mating;
3. reagents related to the detection of human genes;
4. reagents related to genetic disorders;
5. reagents related to narcotic drugs, psychotropic substances, toxic drugs for medical use. Reagents related to the detection of narcotic drugs, psychotropic drugs, and toxic drugs for medical use;
6. Reagents related to the detection of therapeutic drug targets;
7. Reagents related to the detection of tumor markers;
8. Reagents related to the detection of allergic reactions (allergens).
(2) the second category of products: in addition to the products that have been clearly identified as the third category, the first category, the other is the second category of products, mainly including:
1. reagents for protein detection;
2. reagents for the detection of glucose;
3. reagents for hormone testing;
4. Reagents for enzyme detection;
5. Reagents for ester detection;
6. Reagents for vitamin detection;
7. Reagents for inorganic ion detection;
8. Reagents for drug and drug metabolite detection;
9. Reagents for autoantibody detection;
10. Reagents for the identification of microorganisms or drug sensitivity tests;
11. Reagents for the detection of other physiological, biochemical or immune function indicators.
(C) the first category of products:
1. microbial culture medium (not used for microbial identification and drug sensitivity test);
2. sample processing products, such as hemolysate, diluent, staining solution and so on.
Baidu Encyclopedia - In Vitro Diagnostic Reagents