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Diagnostic Reagents Registration Classification

Dec 27, 2017

1. Pathogenic agents and antigens, antibodies and nucleic acids and other detection-related reagents;

2. And blood type, tissue matching related reagents;

3. Reagents related to human genetic testing;

4. Hereditary diseases related reagents;

5. And narcotic drugs, psychotropic drugs, medical toxic drugs testing related reagents;

6. And the treatment of drug target detection related reagents;

7. Tumor markers related reagents;

8. Reagents (allergens) related reagents. The second category of products: In addition to have been clearly classified as the third category, the first category of products, the other for the second category of products, including:

a. reagents for protein detection;

b. reagents for the detection of carbohydrates;

c. reagents for hormone testing;

d. reagents for enzyme detection;

e. Reagents for ester detection;

f. reagents for the detection of vitamins;

g. Reagents for inorganic ion detection;

h. reagents for the detection of drugs and drug metabolites;

i. Reagents for the detection of autoantibodies;

j. Reagents for microbial identification or susceptibility testing;

k. Reagents for the detection of other physiological, biochemical or immune function indicators.

9. Microbial culture medium (not for microbial identification and drug susceptibility testing);

10. Sample processing products, such as hemolytic agents, diluents, staining solution.


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