Microbial Nucleic Acid Storage and Stabilization Device

What Is It?

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

How Is QBD Classified?

Microbial Nucleic Acid Storage And Stabilization Device is FDA product code QBD, Class 2, 21 CFR 866.2950.

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 5 clearances under this code; the FDA took a median of 433 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2020. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are No Marketing Application (4) and Error in labeling (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.