What are the in vitro diagnostic reagents managed as medical devices?

Measures for the Administration of Registration of In Vitro Diagnostic Reagents (State Food and Drug Administration Decree No. 5) Article 3: The in vitro diagnostic reagents referred to in these Measures refer to the in vitro diagnostic reagents managed by medical devices, including reagents, kits, calibrators, and quality control products used for in vitro testing of human samples in the prediction, prevention, diagnosis, therapeutic monitoring, prognostic observation, and evaluation of the health state of the process of the disease. Products. Can be used alone or in combination with instruments, apparatus, equipment or systems. \x0d\\\ In vitro diagnostic reagents for blood screening and in vitro diagnostic reagents labeled with radionuclides, which are managed in accordance with the management of pharmaceuticals, do not fall within the scope of management of this method. \x0d\\\\\x0d\ Article 17 According to the degree of product risk from low to high, in vitro diagnostic reagents are divided into Category I, Category II and Category III products. \x0d\\(I) Category I products\x0d\1. Microbiological culture media (not used for microbial identification and drug sensitivity tests); \x0d\2. Products for sample processing, such as hemolysates, diluents, staining solutions, etc. \x0d\(ii) Category II products\x0d\\ except those which have been specified as Category I and Category III, others are Category II products, mainly including: \x0d\1. reagents for protein testing; \x0d\2. reagents for sugar testing; \x0d\3. reagents for hormone testing; \x0d\4. reagents for enzyme testing; \x0d\5. reagents for ester testing Reagents for the detection of vitamins; \x0d\6. Reagents for the detection of vitamins; \x0d\7. Reagents for the detection of inorganic ions; \x0d\8. Reagents for the detection of drugs and drug metabolites; \x0d\9. Reagents for the detection of auto-antibodies; \x0d\10. Reagents for microbial identification or drug sensitivity tests; \x0d\11. Reagents for other physiological, biochemical or immune Reagents for other physiological, biochemical or immune function indicator tests. \x0d\(C) Category III products \x0d\1. Reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens; \x0d\2. Reagents related to blood grouping and tissue typing; \x0d\3. Reagents related to the detection of human genes; \x0d\4. Reagents related to genetic disorders; \x0d\5. Reagents related to the detection of narcotic drugs, psychotropic substances, and toxic drugs for medical use; \x0d\5. Reagents related to the detection of narcotic drugs, psychotropic substances, and toxic drugs for medical use; \x0d\6. Reagents related to the detection of narcotic drugs and toxic drugs for medical use. Reagents related to the detection; \x0d\6. Reagents related to the detection of therapeutic drug action targets; \x0d\7. Reagents related to the detection of tumor markers; \x0d\8. Reagents related to allergic reactions (allergens).