Tinaquant Complement C4 ver2 3001962322
Tinaquant Complement C4 ver2 3001962322 is a Class II device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K012359 on 29 Nov 2001 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04015630917716), active as of 12 Nov 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04015630917716 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012359 | Date29 Nov 2001 | StatusActive |
Official records
- AccessGUDID record 04015630917716
- FDA 510(k) database K012359
Across registries
- FDA 510(k) K012359 decided 29 Nov 2001 Active
- FDA GUDID UDI-DI 04015630917716 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-0103-2021
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Timeline
- Cleared FDA 510(k) K012359
- Listed FDA GUDID 04015630917716
- Recall initiated FDA recalls Z-0103-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tinaquant Complement C4 ver2
- Generic name
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
- Model / Ref / Catalog
- 3001962322
- Primary DI / UDI-DI
- 04015630917716
- 510(k) Number
- FDA product code
- DBI
- GMDN term
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
- Device class
- Class II
- Regulation number
- 866.5240
- GUDID distribution status
- In Commercial Distribution