Vitros 6199951
Vitros 6199951 is a Class II device made by Ortho-Clinical Diagnostics, granted FDA De Novo DEN210038 on 5 May 2023 and listed in FDA GUDID since 22 Nov 2023 (UDI-DI 10758750033607), active as of 23 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10758750033607 | Date22 Nov 2023 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN210038 | Date5 May 2023 | StatusActive |
Official records
- AccessGUDID record 10758750033607
- FDA De Novo database DEN210038
Across registries
- FDA De Novo DEN210038 decided 5 May 2023 Active
- FDA GUDID UDI-DI 10758750033607 listed 22 Nov 2023 Listed
Timeline
- Granted FDA De Novo DEN210038
- Listed FDA GUDID 10758750033607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- Vitros
- Generic name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
- Model / Ref / Catalog
- 6199951
- Primary DI / UDI-DI
- 10758750033607
- De Novo Number
- FDA product code
- QVP
- GMDN term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3983
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QVP (SARS-CoV-2 serology test).
- Elecsys Anti-SARS-CoV-2 by Roche Diagnostics Corp.
- Elecsys Anti-SARS-CoV-2 S by Roche Diagnostics Corp.
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators by Ortho-Clinical Diagnostics
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator by Ortho-Clinical Diagnostics