QMC

Transport Medium, Notified Per The Vtm Guidance

Product code
QMC
Device name
Transport Medium, Notified Per The Vtm Guidance
Device class
Class 1
21 CFR
21 CFR 866.2390
Medical specialty
Microbiology
Marketing pathway
510(K)

FDA classification definition

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QMC
Classification and pathway per current FDA publications. Data from openFDA (CC0).