Article 3 of the Measures for the Administration of Registration of in vitro Diagnostic Reagents (Order No.5 of China Food and Drug Administration): The in vitro diagnostic reagents mentioned in these Measures refer to the in vitro diagnostic reagents managed by medical devices, including reagents, kits, calibrators, quality control products and other products used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. It can be used alone or in combination with instruments, appliances, equipment or systems. \x0d\ In vitro diagnostic reagents used for blood source screening according to drug management and in vitro diagnostic reagents labeled with radionuclides do not belong to the management scope of these Measures. \x0d\\x0d\ Article 17 According to the degree of product risk from low to high, in vitro diagnostic reagents are divided into Class I, Class II and Class III products. \x0d\ (1) Category I products \x0d\ 1. Microbial culture medium (not used for microbial identification and drug sensitivity test); \x0d\2。 Products used for sample processing, such as hemolytic agent, diluent, dyeing solution, etc. \x0d\ (II) Class II products \x0d\ Except products that have been clearly classified into Class I and Class III, all others are Class II products, mainly including: \x0d\ 1. Protein detection reagent; \x0d\2。 Sugar detection reagent; \x0d\3。 Hormone detection reagent; \x0d\4。 Enzyme detection reagent; \x0d\5。 Ester detection reagent; \x0d\6。 Vitamin detection reagent; \x0d\7。 Inorganic ion detection reagent; \x0d\8。 Reagents for detecting drugs and drug metabolites; \x0d\9。 Autoantibody detection reagent; \x0d\ 10。 Microbial identification or drug sensitivity test reagents; \x0d\ 1 1。 Used to detect other physiological, biochemical or immune function indicators. \x0d\ (3) Products of the third category \x0d\ 1. Reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens; \x0d\2。 Reagents related to blood type and tissue matching; \x0d\3。 Reagents related to human genetic testing; \x0d\4。 Reagents related to hereditary diseases; \x0d\5。 Reagents related to the detection of narcotic drugs, psychotropic drugs and toxic drugs for medical use; \x0d\6。 Reagents related to the detection of therapeutic drug targets; \x0d\7。 Reagents related to the detection of tumor markers; \x0d\8。 Agents related to allergies (allergens).