Nucleic acid test paper belongs to the medical device

The test strips for nucleic acid testing belong to Class III.

Medical devices are categorized into three classes according to the degree of product risk.

The first category includes routine culture media, medical stains, dilutions, etc.;

The third category includes antigens and antibodies to disease-causing pathogens, nucleic acid test reagents, tumor marker test reagents, allergen test reagents, psychotropic substances, drugs, narcotic drug test reagents and other high-risk items of medical items;

The removal of the first category and the third category other than the products belong to the The second category, including enzymes, hormones, sugars and conventional drug metabolism testing items.