ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum AUTOMATED ON-LINE
by RECIPE Chemicals + Instruments GmbH
Ref 21200, 21000
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4049195B21X00AV | Date3 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Trade Name
- ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum AUTOMATED ON-LINEClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum
- Device Name
- Carbohydrate-deficient Transferrin
- Model / Reference
- 21200, 21000
- Primary DI / UDI-DI
- 04049195212009, 04049195210005
- Basic UDI-DI
- 4049195B21X00AV
- Direct Marketing DI
- 0404919521200904049195210005
- EMDN Code
- W01010499 Multiple clin. chem lab reagents - other
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000032553
From the manufacturer
Manufacturer's product page: Complete Kits LC-MS/MS
Other devices from RECIPE Chemicals + Instruments GmbH
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No