Identity
- Trade Name
- Panther Fusion Paraflu Assay Controls Kit EUDAMEDPanther Fusion® FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- Panther Fusion Paraflu Assay EUDAMEDPanther Fusion® Paraflu Controls Kit. FDA UDI
- Model / Reference
- PRD-04337 EUDAMEDPARAFLU CTRLS KIT, PANTHER FUSION, IVD FDA UDI
- Description
- Panther Fusion® Paraflu Controls Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-04337 FDA UDI
- Primary DI / UDI-DI
- 15420045509337 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGPFPARAFLURZ EUDAMED
- Unit of Use DI
- 05420045509330 EUDAMED
- 510(k) Number
- K172282 FDA UDI
- FDA Product Code
- OOU FDA UDIOOI FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple-genus respiratory virus nucleic acid IVD, control
Panther Fusion® by Hologic, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus nucleic acid IVD, control.
- Alinity m — Abbott Molecular · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- Quidel Molecular — DIAGNOSTIC HYBRIDS, INC. · Class I
- Simplexa™ Flu A/B & RSV Positive Control Pack — DiaSorin Molecular LLC · Class II
- NATtrol™ — ZeptoMetrix LLC · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- NATtrol™ — ZeptoMetrix LLC · Class I
Cleared under the same submission
K172282 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI 21346606-f2ce-44a1-a833-80bfcacc0ce0 37 fields · synced Jul 8, 2026
- EUDAMED bc0deb72-82d5-43c5-97b8-868741e43957 61 fields · synced Jul 8, 2026