What type of medical device are the test strips used for nucleic acid testing?

Test strips for nucleic acid detection belong to the third category.

Medical devices are divided into three categories based on the degree of product risk.

The first category includes conventional culture media, medical stains, diluents, etc.;

The third category includes antigens and antibodies of pathogenic pathogens, nucleic acid detection reagents, and tumor marker detection reagents. , allergen testing reagents, psychotropic drugs, drugs, narcotic drug testing reagents and other high-risk medical projects;

Products other than Category 1 and Category 3 belong to Category 2, including enzymes , hormones, sugars and conventional drug metabolism testing items.