← Back to catalogue
Panther Fusion AdV/hMPV/RV Assay
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref PRD-04330
by Hologic
Identity
- Trade Name
- Panther Fusion AdV/hMPV/RV Assay EUDAMEDPanther Fusion® FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Panther Fusion AdV/hMPV/RV Assay EUDAMEDThe Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV). FDA UDI
- Model / Reference
- PRD-04330 EUDAMEDAMR KIT, PANTHER FUSION, 96T, IVD FDA UDI
- Description
- The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV). FDA UDI
Identifiers
- Catalog Number
- PRD-04330 FDA UDI
- Primary DI / UDI-DI
- 15420045509290 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGPFAdVhMPVRVZ2 EUDAMED
- Unit of Use DI
- 05420045509293 EUDAMED
- FDA Product Code
- OCC FDA UDIOOI FDA UDIOEM FDA UDI
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) 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 by Hologic Inc. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231017 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K172629 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 54200455DIAGPFAdVhMPVRVZ2 | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED fabb8fc8-75c8-4e1a-9e48-fcf8f60e166b 61 fields · synced Jul 15, 2026
- FDA UDI 30f177f7-e2a6-456c-8747-3394f73f73ee 36 fields · synced May 29, 2026
- FDA 510(k) K231017 1 fields · synced May 18, 2026