What Is This Device?
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
What Is FDA Product Code QYT?
Over-The-Counter Covid-19 Antigen Test is FDA product code QYT, Class 2, 21 CFR 866.3984.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 143 days from receipt to decision.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2024. 3 were by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.