ClinDART® Complete Kit for Mycophenolic Acid in Serum and Plasma
by RECIPE Chemicals + Instruments GmbH Germany EUDAMED
Ref MS100000
EMDN W01010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4049195CMS100000KF | Date8 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Mycophenolic Acid in Serum / Plasma, Tdm, Dart - Ms/Ms
- Model / Reference
- MS100000
- Primary DI / UDI-DI
- 04049195008329
- Basic UDI-DI
- 4049195CMS100000KF
- Direct Marketing DI
- 04049195008329
- EMDN Code
- W01010499 Multiple clin. chem lab reagents - other
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000032553
From the manufacturer
Manufacturer's product page: Complete Kits LC-MS/MS
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 4aab27c6-eeac-490f-b63f-639ed096767e