Transystem™ 108C.USE
Transystem™ 108C.USE is a Class I device made by Copan Italia SpA, cleared under FDA 510(k) K972448 on 20 Aug 1997 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 28053326000588), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number28053326000588 | Date7 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK972448 | Date20 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 28053326000588
- FDA 510(k) database K972448
Across registries
- FDA 510(k) K972448 decided 20 Aug 1997 Active
- FDA GUDID UDI-DI 28053326000588 listed 7 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K972448
- Listed FDA GUDID 28053326000588
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Transystem™
- Generic name
- General specimen collection kit
- Model / Ref / Catalog
- 108C.USE
- Primary DI / UDI-DI
- 28053326000588
- 510(k) Number
- FDA product code
- JSL
- GMDN term
- General specimen collection kit
- Device class
- Class I
- Regulation number
- 866.2390
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JSL (Culture Media, Anaerobic Transport).
- ANAEROBIC TRANSPORT MEDIUM by Anaerobe Systems
- BIONOR TRANSPORTMEDIUM by Skoug Research Corp.
- KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM by Starplex Scientific, Inc.
- ANA TRANS TUBE & SWABS STERILE PACK by Anaerobe Systems
- PRE-DUCED CULTURE MEDIA by Gibco Laboratories Life Technologies, Inc.
- PRE-REDUCED ANAEROBIC MEDIA by Gibco Laboratories Life Technologies, Inc.