QMC · Transport Medium, Notified Per The Vtm Guidance
Microbiology · 21 CFR 866.2390 · Class 1
Overview
| Product Code | QMC |
|---|---|
| Device Name | Transport Medium, Notified Per The Vtm Guidance |
| Regulation | 21 CFR 866.2390 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
