Vitros 6802303
Vitros 6802303 is a Class I device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 8 Apr 2020 (UDI-DI 10758750002528), 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 | Number10758750002528 | Date8 Apr 2020 | StatusListed |
Official records
- AccessGUDID record 10758750002528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Troponin I IVD, kit, chemiluminescent immunoassay
- Model / Ref / Catalog
- 6802303
- Primary DI / UDI-DI
- 10758750002528
- FDA product code
- JJX
- GMDN term
- Troponin I IVD, kit, chemiluminescent immunoassay
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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