What Is This Device?
Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).
How Is QMC Classified?
Transport Medium, Notified Per The Vtm Guidance is FDA product code QMC, Class 1, 21 CFR 866.2390.
What Does It Take to Sell It in the United States?
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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Do the Recalls Say?
The FDA has recorded 4 recalls under this product code since 2022. 3 were by a company in China. 3 are Class I, the most serious grade.
The root causes the FDA records most often are No Marketing Application (3) and Labeling mix-ups (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.