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"Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassett…
EUDAMEDClass IVD General (EU MDR)
Ref IF031
Identity
- Device Name
- "Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Test Cassette (Rare earth nanorare earth nano fluorescence immunochromatography)" EUDAMED
- Model / Reference
- IF031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013518 EUDAMED
- Basic UDI-DI
- B-06974323013518 EUDAMED
- EMDN Code
- W0105010799 MYCOBACTERIA REAGENTS - OTHER 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 Specific Cell Mediated Immune Response Test Cassett… 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-06974323013518 | 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 4de7b7c7-40ab-434b-882d-207ab27477ec 61 fields · synced Jun 19, 2026