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Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Met…
EUDAMEDClass IVD General (EU MDR)
Ref IH021
Identity
- Device Name
- Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Method) EUDAMED
- Model / Reference
- IH021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011842 EUDAMED
- Basic UDI-DI
- B-06974323011842 EUDAMED
- EMDN Code
- W0105010702 MYCOBACTERIAL ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Mycobacterium Tuberculosis IgG Antibody Rapid Test Cassette (Colloidal Gold Met… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974323011842 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 899f2a04-6c4c-4bf8-8a72-c562924d685d 61 fields · synced Jul 25, 2026