Product code QMC

Device name

Transport Medium, Notified Per The Vtm Guidance

Medical specialty

Microbiology

Device class

1

Regulation number

866.2390

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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).

Source

FDA openFDA device classification dataset