IVD reagents are divided into Class I, II
and III, according to the product’s level of risk.
Class I products
1. Microbiological
culture media (not used for microbial identification or susceptibility
testing);
2. Products
for sample treatment, such as hemolytic agent, diluent, dye solution.
Class II products
Products that are not specified as Class I
or Class III product are Class II product, mainly including:
1. Reagents
for the detection of protein;
2. Reagents
for the detection of sugars;
3. Reagents
for the detection of hormone;
4. Reagents
for the detection of enzymes;
5. Reagents
for the detection of esters;
6. Reagents
for the detection of vitamin;
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
used for microbial identification or drug sensitivity test;
11. Reagents
for the detection of other physiological, biochemical or immunological
functional indicators.
Class III products
1. Reagents
related to the detection of antigens, antibodies, and nucleic acid of
pathogens;
2. Reagents
related to blood type and tissue type;
3. Reagents
related to the detection of human genetic;
4. Reagents
related to genetic diseases;
5. Reagents
related to the detection of narcotics, psychotropic substances and toxic drugs
for medical use;
6. Reagents
related to the detection of targets for drugs;
7. Reagents
related to the detection of tumor markers;
8. Reagents
related to allergic reactions (allergens).
If you need to accurately determine the
classification of your products or want to know more about classification
rules, please contact us via:
Tel: 86-10-62253808
Email: service@qiminer.com