Anti-MPO IgG CLIA Microparticles
by Autobio Diagnostics Co., Ltd. China EUDAMED
Ref CMQ1605Model AutoLumo analyzer EMDN W0102100402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697015090000314HA | Date14 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- AutoLumo analyzer, CMQ1605
- Primary DI / UDI-DI
- 06942359545587
- Basic UDI-DI
- 697015090000314HA
- EMDN Code
- W0102100402 Mpo anca
- Device Class
- Class B
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000003348
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Autobio Diagnostics Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED d3345a19-b1ed-4c54-81f7-b85f39a4639c