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PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR)
EUDAMEDClass IVD General (EU MDR)
Ref ID022
Identity
- Device Name
- PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- ID022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012931 EUDAMED
- Basic UDI-DI
- B-06974323012931 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS 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
PCR-based Mycobacterium Tuberculosis Complex Test Kit (Fluorometric PCR) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD…
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-06974323012931 | 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 fc24cd40-7312-40a5-af82-42e7399fd74c 61 fields · synced Aug 1, 2026