Vitros 6177746
Vitros 6177746 is a Class II device made by Ortho-Clinical Diagnostics, cleared under FDA 510(k) K221355 on 12 Dec 2022 and listed in FDA GUDID since 14 Mar 2023 (UDI-DI 10758750034826), 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 | Number10758750034826 | Date14 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221355 | Date12 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 10758750034826
- FDA 510(k) database K221355
Across registries
- FDA 510(k) K221355 decided 12 Dec 2022 Active
- FDA GUDID UDI-DI 10758750034826 listed 14 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K221355
- Listed FDA GUDID 10758750034826
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vitros
- Generic name
- Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
- Model / Ref / Catalog
- 6177746
- Primary DI / UDI-DI
- 10758750034826
- 510(k) Number
- FDA product code
- LTK
- GMDN term
- Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
- Device class
- Class II
- Regulation number
- 866.6010
- GUDID distribution status
- In Commercial Distribution