ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)
by RECIPE Chemicals + Instruments GmbH
Ref MS10000, MS2100, MS10300
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 | Number4049195CMS10X00PS | Date4 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- Withdrawn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
- ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)ClinSpot®ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates, non-derivatised
- Device Name
- Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)ClinSpot® Complete Kit for Homocysteine in Dried Blood Spots (DBS)
- Model / Reference
- MS10000, MS2100, MS10300
- Primary DI / UDI-DI
- 04049195005786, D-MS2100AF, 04049195006943
- Basic UDI-DI
- 4049195CMS10X00PS, B-MS2100AF
- Direct Marketing DI
- 0404919500578604049195006943
- EMDN Code
- W01010402, W01021307
- Device Class
- Class CClass IVD General
- 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