COPAN VIRAL TRANSYSTEM
Device Facts
| Record ID | K001780 |
|---|---|
| Device Name | COPAN VIRAL TRANSYSTEM |
| Applicant | Copan Diagnostics, Inc. |
| Product Code | JSM · Microbiology |
| Decision Date | Jul 31, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2390 |
| Device Class | Class 1 |
Regulatory Classification
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.
