According to the degree of product risk, medical devices are divided into three categories.
The first category includes conventional culture medium, medical dyeing solution, diluent and so on.
The third category includes high-risk medical items such as antigen antibodies of pathogenic pathogens, nucleic acid detection reagents, tumor marker detection reagents, allergen detection reagents, psychotropic drugs, drugs and narcotic drugs detection reagents;
All products except the first and third categories belong to the second category, including enzymes, hormones, sugar and routine drug metabolism detection items.