Vitros 6842905
Vitros 6842905 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 10 Aug 2016 (UDI-DI 10758750030729), 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 | Number10758750030729 | Date10 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10758750030729
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay
- Model / Ref / Catalog
- 6842905
- Primary DI / UDI-DI
- 10758750030729
- FDA product code
- PDJ
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay
- Device class
- Class II
- Regulation number
- 862.1373
- GUDID distribution status
- In Commercial Distribution
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