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Human CYP2C19 Gene Polymorphism Detection Kit (Fluorometric PCR)
EUDAMEDClass IVD General (EU MDR)
Ref ID013
Identity
- Device Name
- Human CYP2C19 Gene Polymorphism Detection Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- ID013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012801 EUDAMED
- Basic UDI-DI
- B-06974323012801 EUDAMED
- EMDN Code
- W0106030104 CYP2C19 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
Human CYP2C19 Gene Polymorphism Detection Kit (Fluorometric PCR) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974323012801 | 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 b69ef2ec-3b2c-4fd4-ad14-89997bc5d435 61 fields · synced Jul 23, 2026