CRP with integrated capillary test kit (32 tests)
Ref ST0102
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-ST0102CW | Date21 Nov 2023 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- ST0102
- Primary DI / UDI-DI
- D-ST0102CW
- Basic UDI-DI
- B-ST0102CW
- EMDN Code
- W0102160601 C-reactive protein - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000013746
Other devices from EUROLyser Diagnostica GmbH
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No