Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
TDM/DRUG CONTROLS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00380740101220
- Basic UDI-DI Code
- B-00380740101220
- Reference
- 5P04-21
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Microgenics Corporation
Additional Description
The TDM Multiconstituent Calibrator is for in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum or plasma assays on the ARCHITECT cSystems. Lot-specific calibrator values for the ARCHITECT cSystems are listed in the TDM Multiconstituent Calibrator Value Sheet, packaged with the calibrator.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152001 | TDM/DRUG CONTROLS |
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