Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther …
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Panther Fusion Flu A/B/RSV 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 Flu A/B/RSV Assay EUDAMEDThe Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). FDA UDI
- Model / Reference
- PRD-04328 EUDAMEDFLU A B RSV, PANTHER FUSION, 96T, IVD FDA UDI
- Description
- The Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). FDA UDI
Identifiers
- Catalog Number
- PRD-04328 FDA UDI
- Primary DI / UDI-DI
- 15420045509283 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGPFFLUABRSVWG EUDAMED
- Unit of Use DI
- 05420045509286 EUDAMED
- 510(k) Number
- FDA Product Code
- OCC FDA 510(k)FDA UDIOOI FDA UDI
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - 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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.3980 FDA 510(k)
- Regulation Number
- 866.3980 FDA 510(k)FDA UDI862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
The Panther Fusion Flu A/B/RSV Assay is a Respiratory Virus Panel Nucleic Acid Assay System, designed for the molecular detection of influenza A, influenza B, and respiratory syncytial virus (RSV) from clinical specimens. This in vitro diagnostic device amplifies and detects viral RNA sequences through automated nucleic acid testing, enabling rapid and accurate identification of respiratory pathogens.
The system comprises disposable components, including the Panther Fusion Assay Fluids I-S Kit, Universal Fluids Kit, and Specimen Lysis Tubes, which are intended for single-use in a laboratory setting. Compliance is achieved through FDA 510(k) clearance and IVDR conformity, ensuring adherence to regulatory standards for microbiological diagnostics. Specimens are processed on the Panther Fusion platform, a fully automated system requiring no manual extraction, with results generated within hours of sample receipt.
Frequently asked questions
What respiratory viruses does the Panther Fusion Flu A/B/RSV Assay detect, and how does it work?
The Panther Fusion Flu A/B/RSV Assay detects influenza A, influenza B, and respiratory syncytial virus (RSV) through automated nucleic acid testing. It amplifies and detects viral RNA sequences from clinical specimens, enabling rapid and accurate identification of these respiratory pathogens. The system is designed for use on the Panther Fusion platform, which handles sample processing and nucleic acid extraction fully automatically, delivering results within hours of sample receipt.
Are the Panther Fusion Assay Fluids I-S Kit, Universal Fluids Kit, and Specimen Lysis Tubes reusable or single-use?
The Panther Fusion Assay Fluids I-S Kit, Universal Fluids Kit, and Specimen Lysis Tubes are explicitly designed for single-use in a laboratory setting. This ensures consistency, sterility, and compliance with best practices for molecular diagnostics, reducing the risk of cross-contamination between samples.
What regulatory pathways does this device follow, and what does that mean for users?
The Panther Fusion Flu A/B/RSV Assay holds FDA 510(k) clearance and IVDR conformity, meaning it meets U.S. and European Union regulatory standards for in vitro diagnostics. This ensures the device’s safety, performance, and compliance with microbiological testing requirements, providing users with confidence in its clinical validity and reliability for detecting respiratory viruses.
How is the Panther Fusion Flu A/B/RSV Assay supplied, and what components are included?
The assay is supplied as part of the Panther Fusion system, which includes disposable components like the Assay Fluids I-S Kit, Universal Fluids Kit, and Specimen Lysis Tubes—all intended for single-use. These components work together with the automated platform to process clinical specimens without manual extraction, streamlining workflows in microbiology laboratories.
Is the Panther Fusion platform fully automated, and what does that mean for workflow efficiency?
Yes, the Panther Fusion platform is fully automated, handling all steps of nucleic acid extraction, amplification, and detection without manual intervention. This eliminates human error, reduces hands-on time, and accelerates turnaround time—typically delivering results within hours of sample receipt, which is critical for managing respiratory virus outbreaks in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171963 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (3)
- FDA 510(k) K171963 24 fields · synced Oct 6, 2026
- FDA UDI da2c5895-cfa3-4c18-8c9c-4f5998281eee 37 fields · synced May 30, 2026
- EUDAMED a1aa30b0-d84c-4584-8bb6-b07cab9171ff 61 fields · synced Jul 9, 2026