QMC — Transport Medium, Notified Per The Vtm Guidance Class I

FDA Device Classification

FDA product code QMC covers "Transport Medium, Notified Per The Vtm Guidance", a Class I medical device regulated under 21 CFR 866.2390. Submissions are reviewed by the Microbiology panel.

Classification Details

Product Code
QMC
Device Class
Class I
Regulation Number
866.2390
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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).