DeviceClearance

Product code QBD— Microbiology

Biosci Inactivated Transport Medium, Biosci ITM

Classification name
Microbial Nucleic Acid Storage And Stabilization Device
Device class
Class 2
Regulation
21 CFR 866.2950
Advisory panel
Microbiology
Total cleared
17
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QBD under 21 CFR 866.2950, via openFDA

Market context for product code QBD

FDA has cleared 17 devices under product code QBD between 2018 and 2025, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBD

Recent clearances under product code QBD

Data sourced from openFDA. This site is unofficial and independent of the FDA.