Cfas PUC 3121305122
Cfas PUC 3121305122 (03121305122) is a Class II device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K050026 on 31 Jan 2005 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04015630918805), active as of 12 Nov 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 | Number04015630918805 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050026 | Date31 Jan 2005 | StatusActive |
Official records
- AccessGUDID record 04015630918805
- FDA 510(k) database K050026
Across registries
- FDA 510(k) K050026 decided 31 Jan 2005 Active
- FDA GUDID UDI-DI 04015630918805 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K050026
- Listed FDA GUDID 04015630918805
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cfas PUC
- Generic name
- Plasma protein IVD, calibrator
- Model / Ref / Catalog
- 3121305122, 03121305122
- Primary DI / UDI-DI
- 04015630918805
- FDA product code
- JIX
- GMDN term
- Plasma protein IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Plasma protein IVD, calibrator.