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Panther Fusion AdV/hMPV/RV Assay Controls Kit
EUDAMEDFDA UDIClass B (EU MDR)
Ref PRD-04338
by Hologic
Identity
- Trade Name
- Panther Fusion AdV/hMPV/RV Assay Controls Kit EUDAMEDPanther Fusion® FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- Panther Fusion AdV/hMPV/RV Assay EUDAMEDPanther Fusion® AdV/hMPV/RV Controls Kit. FDA UDI
- Model / Reference
- PRD-04338 EUDAMEDAMR CTRLS, PANTHER FUSION, IVD FDA UDI
- Description
- Panther Fusion® AdV/hMPV/RV Controls Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-04338 FDA UDI
- Primary DI / UDI-DI
- 15420045509320 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGPFAdVhMPVRVZ2 EUDAMED
- Unit of Use DI
- 05420045509323 EUDAMED
- 510(k) Number
- K172629 FDA UDI
- FDA Product Code
- OCC FDA UDIOOI FDA UDIOEM FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3980 FDA UDI862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Panther Fusion AdV/hMPV/RV Assay Controls Kit by Hologic Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54200455DIAGPFAdVhMPVRVZ2 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED 617dc202-de7f-4870-be09-38d99b83f3af 61 fields · synced Jun 18, 2026
- FDA UDI 2266f372-2e66-40f4-a2bd-59da8b7deb42 37 fields · synced May 30, 2026