beta-Hydroxybutyrate, Enzymatic, UV
by DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H. 6 variants
Ref D18027
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-D18027V5 D-D18027V5 | Date11 Jun 2026 | StatusActive |
Certificates
No certifier 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- Withdrawn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
- Device Name
- beta-Hydroxybutyrate, Enzymatic, UV
- Model / Reference
- D18027
- Primary DI / UDI-DI
- D-D18027V5
- Basic UDI-DI
- B-D18027V5
- EMDN Code
- W01010118 Hydroxybutyrate dehydrogenase
- Device Class
- Class IVD General
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000000254
Other devices from DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No