Tinaquant Complement C3c ver2 5991986190
Tinaquant Complement C3c ver2 5991986190 is a Class II device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K012361 on 29 Nov 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04015630928422), 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 | Number04015630928422 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012361 | Date29 Nov 2001 | StatusActive |
Official records
- AccessGUDID record 04015630928422
- FDA 510(k) database K012361
Across registries
- FDA 510(k) K012361 decided 29 Nov 2001 Active
- FDA GUDID UDI-DI 04015630928422 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K012361
- Listed FDA GUDID 04015630928422
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tinaquant Complement C3c ver2
- Generic name
- Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
- Model / Ref / Catalog
- 5991986190
- Primary DI / UDI-DI
- 04015630928422
- 510(k) Number
- FDA product code
- CZW
- GMDN term
- Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5240
- GUDID distribution status
- In Commercial Distribution