CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
Device Facts
| Record ID | K936078 |
|---|---|
| Device Name | CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED |
| Applicant | Medical Packaging Corp. |
| Product Code | JSM · Microbiology |
| Decision Date | Aug 16, 1994 |
| 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.
