Vitros 1662659
Vitros 1662659 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10758750009503), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10758750009503 | Date23 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10758750009503
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Multiple-type clinical chemistry analyte profile IVD, calibrator
- Model / Ref / Catalog
- 1662659
- Primary DI / UDI-DI
- 10758750009503
- FDA product code
- JIX
- GMDN term
- Multiple-type clinical chemistry analyte profile 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 Multiple-type clinical chemistry analyte profile IVD, calibrator.
- Dimension® Thyroid Calibrator 10445018 RC410 by Siemens Healthcare Diagnostics Inc.
- CAL 3 CAL2351 by Randox Laboratories, Ltd.
- Immunalysis 10002-25 by Immunalysis Corporation
- Immunalysis 10003-15 by Immunalysis Corporation
- Dimension Vista® System PSA CAL 10464359 KC602 by Siemens Healthcare Diagnostics Inc.
- Alinity 08P6001 by Abbott
- ARCHITECT 1E65-06 01E6506 by Abbott
- ABX PENTRA MULTICAL 1220001652 by Horiba Abx
- CAL 2 CAL2350 by Randox Laboratories, Ltd.
- ARCHITECT 04V1501 by ABBOTT IRELAND