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Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B
EUDAMEDClass IVD General (EU MDR)
Ref CT8012-48TRef CT8012-24TRef ID004
Identity
- Device Name
- Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B EUDAMED
- Model / Reference
- CT8012-48T EUDAMEDCT8012-24T EUDAMEDID004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012146 EUDAMED06974323012139 EUDAMED06974323012658 EUDAMED
- Basic UDI-DI
- B-06974323012146 EUDAMEDB-06974323012139 EUDAMEDB-06974323012658 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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
Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B 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-06974323012146 | 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 (3)
- EUDAMED 9065d5e2-ff81-4ce9-8a01-be87213fec75 61 fields · synced Jul 10, 2026
- EUDAMED 4614650b-1874-4ec6-9b79-8b8772a93338 61 fields · synced May 16, 2026
- EUDAMED 34de1117-2283-411c-9499-768223144e43 61 fields · synced Jul 9, 2026