Based on the degree of risk of the product, in vitro diagnostic reagents are categorized into Class III, Class II and Class I products.
The third category of products:
1, reagents related to the detection of pathogenic pathogens antigens, antibodies, and nucleic acids;
2, reagents related to the blood type, tissue mating;
3, reagents related to the detection of human genes;
4, reagents related to hereditary diseases;
5, and narcotic drugs, Psychotropic drugs, toxic drugs for medical use;
6, reagents related to the detection of therapeutic drug action targets;
7, reagents related to the detection of tumor markers;
8, reagents related to allergic reactions (allergens).
The second category of products: in addition to the products that have been specified as the third category and the first category, the other products are the second category, mainly including:
1. Reagents used for protein detection;
2. Reagents used for the detection of sugars;
3. Reagents used for the detection of hormones;
4. Reagents used for the detection of enzymes;
5. Reagents for ester detection;
6. Reagents for vitamin detection;
7. Reagents for the detection of inorganic ions;
8. Reagents for the detection of drugs and drug metabolites;
9. Reagents for the detection of autoantibodies;
10. Reagents for the identification of microorganisms or for drug sensitivity tests;
11, Reagents for other physiological, biochemical or immune function indicator tests.
The first category of products:
1, microbial culture medium (not used for microbial identification and drug sensitivity test);
2, products for sample treatment, such as hemolytic agent, diluent, staining solution and so on.
Extended information:
. p>Domestic in vitro diagnostics are mainly concentrated in 3 major areas:
Biochemical diagnostic reagents market, immunodiagnostic reagents market and hematology and flow cytometry market.
Biochemical diagnostic reagent market and immunodiagnostic reagent market will remain the two largest markets, accounting for 60% of the market share. Biochemical diagnostic reagents are more mature both internationally and domestically, and have basically completed domestic substitution in the domestic market.
Immuno-diagnostic enzyme immunization and colloidal gold are widely used, chemiluminescent diagnostics has been rapid development, in the immuno-diagnostic market occupies an increasingly heavy proportion; molecular diagnostic reagents market is the future of the more potential market segments, but also the implementation of precision medicine is an important technological prerequisite for the implementation of the basic foundation, on behalf of the diagnostic technology cutting-edge direction, the future for quite some time will still be maintained at a relatively high rate of growth.
Medical device special rectification:
March 17, 2014, the State Food and Drug Administration held a press conference, from now on, the State Food and Drug Administration will focus on a five-month nationwide medical device "five rectification" special action, focusing on the rectification of medical device false The five behaviors of false registration declaration, illegal production, illegal operation, expanding publicity, the use of unlicensed products.
Special action to focus on key products, key enterprises, key cases as a breakthrough, through unannounced visits to the investigation, centralized investigation, raids and inspections of a combination of ways to crack down on illegal behavior, and further standardize the market order.
The State Food and Drug Administration requires that the special action, found violations of the law, all from the fast, strict, serious treatment, and in accordance with the laws and regulations of the upper limit to be punished.
The circumstances are serious, all the production operators and product license revocation; suspected of crime, all transferred to the public security organs to investigate criminal responsibility; the existence of hidden safety risks of the product, all stop the sale and use, and ordered the enterprise recall and supervise the destruction.
Baidu Encyclopedia - In Vitro Diagnostic Reagents