JSL · Culture Media, Anaerobic Transport
Microbiology · 21 CFR 866.2390 · Class 1
Overview
| Product Code | JSL |
|---|---|
| Device Name | Culture Media, Anaerobic Transport |
| Regulation | 21 CFR 866.2390 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Copan Italia Spa | Aug 20, 1997 | SESE |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Copan Italia Spa | Aug 20, 1997 | SESE |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Starplex Scientific, Inc. | Feb 16, 1995 | SESE |
| K925450 | BIONOR TRANSPORTMEDIUM | Skoug Research Corp. | Jun 25, 1993 | SESE |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Anaerobe Systems | Apr 4, 1984 | SESE |
| K834357 | ANA TRANS TUBE & SWABS STERILE PACK | Anaerobe Systems | Jan 31, 1984 | SESE |
| K770840 | PRE-REDUCED ANAEROBIC MEDIA | Gibco Laboratories Life Technologies, Inc. | Jun 8, 1977 | SESE |
| K770650 | PRE-DUCED CULTURE MEDIA | Gibco Laboratories Life Technologies, Inc. | Apr 15, 1977 | SESE |
Top Applicants
- Anaerobe Systems — 2 clearances
- Copan Italia Spa — 2 clearances
- Gibco Laboratories Life Technologies, Inc. — 2 clearances
- Skoug Research Corp. — 1 clearance
- Starplex Scientific, Inc. — 1 clearance
