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Alinity c Benzodiazepines Reagent Kit
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 09P5220
Identity
- Device Name
- Alinity c Benzodiazepines Reagent Kit EUDAMED
- Model / Reference
- 09P5220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884883007994 EUDAMED
- Basic UDI-DI
- B-00884883007994 EUDAMED
- EMDN Code
- W0102090104 BENZODIAZEPINES 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
Alinity c Benzodiazepines Reagent Kit by Microgenics Corporation — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243498 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00884883007994 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED 9f5c2430-d9c6-4a70-8c0c-97a28df3daf0 61 fields · synced Jul 9, 2026
- FDA 510(k) K243498 1 fields · synced May 18, 2026