CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe
by Cytocell Limited United Kingdom EUDAMED
Ref CE-LPH 022
EMDN W01060211
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number50558449LPH022J9 | Date4 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- CE-LPH 022
- Primary DI / UDI-DI
- 05055844906341, 05055844923591
- Basic UDI-DI
- 50558449LPH022J9
- EMDN Code
- W01060211 Inv (16)
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000016893
- Authorised representative
- Sysmex Europe SE DE-AR-000022333
Other devices from Cytocell Limited
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 47a8a82f-e06e-4ab3-87f0-352b3d5a795c
- EUDAMED f71e27e9-0b1c-44f5-9c5e-dc69e3f03317