Vitros 6800876
Vitros 6800876 is a Class I device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 6 Jun 2020 (UDI-DI 10758750000968), 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 | Number10758750000968 | Date6 Jun 2020 | StatusListed |
Official records
- AccessGUDID record 10758750000968
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Total prostate specific antigen (tPSA) IVD, control
- Model / Ref / Catalog
- 6800876
- Primary DI / UDI-DI
- 10758750000968
- FDA product code
- JJX
- GMDN term
- Total prostate specific antigen (tPSA) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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