Anti-Ki-67
by DB Biotech, a.s. Slovakia EUDAMED
Ref DB 318-1Model DB 318
EMDN W01030705
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number85850389DB318LE | Date25 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- DB 318, DB 318-1
- Primary DI / UDI-DI
- 08585038904718
- Basic UDI-DI
- 85850389DB318LE
- EMDN Code
- W01030705 Fixing reagents (histology/cytology)
- Device Class
- Class C
- Market of Registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- SK-MF-000051838
Other devices from DB Biotech, a.s.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 4b0b38a2-94d0-4a0a-9a56-abcc3655782e