According to the product risk degree, in-vitro diagnosis reagents are successively classified into Class III, Class II and Class I products.

(I) Class III products:

1. Reagents related to the inspection of antigen, antibody and nucleic acid, etc. for pathogen;

2. Reagents related to blood group and tissue typing;

3. Reagents related to the inspection of human gene;

4. Reagents related to inherited diseases;

5. Reagents related to the inspection of narcotic drugs, psychotropic drugs and toxic drugs for medical use;

6. Reagents related to the inspection of targets sites of curative drugs;

7. Reagents related to the inspection of tumor markers;

8. Reagents related to allergy (allergen).

(II) Class II products: products not clearly defined as Class III and Class I products are Class II products, mainly including:

1. Reagents used for protein inspection;

2. Reagents used for carbohydrate inspection;

3. Reagents used for hormone inspection;

4. Reagents used for enzymes inspection;

5. Reagents used for esters inspection;

6. Reagents used for vitamin inspection;

7. Reagents used for inorganic ion inspection;

8. Reagents used for the inspection of drugs and drug metabolites;

9. Reagents used for auto-antibody inspection;

10. Reagents used for microorganism identification and medicine sensitivity experiment;

11. Reagents used for the inspection of indexes for other physiological, biochemical and immune functions. 

(III) Class I products:

1. Microorganism culture medium (not used for microorganism identification and medicine sensitivity experiment);

2. Products for specimen treatment, e.g. hemolytic agents, diluents, staining solutions, etc.