Transport Medium, Notified Per The Vtm Guidance
The Transport Medium notified per the VTM Guidance is a specimen collection and transport device intended for use in the detection of respiratory viruses including coronavirus, as outlined in the FDA's guidance on notified transport media. It is a Class 1 device subject to general controls under regulation 866.2390 in the Microbiology specialty. Product code QMC. As a Class 1 device it is the lowest regulatory tier, relying on general controls to ensure safety and effectiveness, though it is not GMP exempt in this case. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QMC
- Device Class
- FDA class 1
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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).
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.