Vitros 1668409
Vitros 1668409 is a Class I device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 18 Apr 2020 (UDI-DI 10758750009510), 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 | Number10758750009510 | Date18 Apr 2020 | StatusListed |
Official records
- AccessGUDID record 10758750009510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Lipase IVD, reagent
- Model / Ref / Catalog
- 1668409
- Primary DI / UDI-DI
- 10758750009510
- FDA product code
- CHI
- GMDN term
- Lipase IVD, reagent
- Device class
- Class I
- Regulation number
- 862.1465
- GUDID distribution status
- In Commercial Distribution
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