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Panther Fusion MRSA Assay Controls
EUDAMEDClass C (EU MDR)
Ref PRD-04805
by Hologic
Identity
- Trade Name
- Panther Fusion MRSA Assay Controls EUDAMED
- Device Name
- Panther Fusion MRSA Assay EUDAMED
- Model / Reference
- PRD-04805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045510449 EUDAMED
- Basic UDI-DI
- 54200455DIAGPFMRSADE EUDAMED
- Unit of Use DI
- 05420045510442 EUDAMED
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium 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
New Device
No
EUDAMED
Panther Fusion MRSA Assay Controls by Hologic Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54200455DIAGPFMRSADE | Class C | Active |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED 274b5a62-6116-4c58-8320-470d460e326f 61 fields · synced Jul 16, 2026