21 CFR 866.2390 — Culture Media, Anaerobic Transport
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2390
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JSL | Culture Media, Anaerobic Transport | 1 | 8 | 3rd Party |
| JSM | Culture Media, Non-Propagating Transport | 1 | 111 | 3rd Party |
| JSN | Culture Media, Propagating Transport | 1 | 13 | 3rd Party |
| QMC | Transport Medium, Notified Per The Vtm Guidance | 1 | 0 |
