KOMBITEST T Cell 4-color
by EXBIO Praha, a.s. EUDAMED
Active
Ref ED7734
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number859420806ED773476 | Date26 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 2024-IVDR/QS-004 Supplemented
Quality management system EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 4 Dec 2024
- Expires
- 11 Jun 2029
- Reason
- Add device or group
Specification
- Device Name
- KOMBITEST T Cell 4-color
- Model / Reference
- ED7734
- Primary DI / UDI-DI
- 08594208060024
- Basic UDI-DI
- 859420806ED773476
- Direct Marketing DI
- 08594208060024
- EMDN Code
- W0103080106 Antibodies for lymphocyte subtyping
- Device Class
- Class C
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000033468
Other devices from EXBIO Praha, a.s.
Properties
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