Vitros 8568040
Vitros 8568040 is a multiple-therapy therapeutic drug monitoring IVD (FDA Class II; FDA product code JIT, Calibrator, Secondary) made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 10 Aug 2016 (UDI-DI 10758750005031), 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 | Number10758750005031 | Date10 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10758750005031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Vitros
- Generic name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator
- Model / Ref / Catalog
- 8568040
- Primary DI / UDI-DI
- 10758750005031
- FDA product code
- JIT
- GMDN term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple-therapy therapeutic drug monitoring IVD, calibrator.
- Dimension® DRUG Calibrator 10445014 DC22B by Siemens Healthcare Diagnostics Inc.
- Dimension® DRUG Calibrator II 10445005 DC49D by Siemens Healthcare Diagnostics Inc.
- Plasma Calibrator Set 92052 by Chromsystems Instruments & Chemicals GmbH
- CEDIA Antibiotic TDM Multi-Cal 08777934 190 by Microgenics Corporation
- Plasma Calibrator Set 92053 by Chromsystems Instruments & Chemicals GmbH
- Synchron 471080 by Beckman Coulter, Inc.