Vitros 8001133
Vitros 8001133 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10758750004201), 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 | Number10758750004201 | Date23 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10758750004201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
- Model / Ref / Catalog
- 8001133
- Primary DI / UDI-DI
- 10758750004201
- FDA product code
- JHS
- GMDN term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1215
- GUDID distribution status
- In Commercial Distribution
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- CARDIOZYME PLUS CK-TOTAL #65046 by Harleco
- ADVIA Centaur® CKMB 10309982 110773 by Siemens Healthcare Diagnostics Inc.