Carbohydrate Antigen 72-4(CA72-4)Detection Kit(Magnetic Solid Phase Chemiluminescent Immunoassay)
by Biobase Diagnostic Technology (Shandong) Co., Ltd. China EUDAMED
Ref 100 Tests/kit(DR1092-2)Model 100 Tests/kit
EMDN W0102030105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974969981899 | Date11 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Model / Reference
- 100 Tests/kit, 100 Tests/kit(DR1092-2)
- Primary DI / UDI-DI
- 06974969981899
- Basic UDI-DI
- B-06974969981899
- EMDN Code
- W0102030105 Cancer antigen 72-4
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025964
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 2c654002-4e3b-4507-80e7-6e07a95b405e