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Panther Fusion Paraflu Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172282

by Hologic, Inc.

Identifiers

510(k) Number
K172282 FDA 510(k)
FDA Product Code
OOU FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3980 FDA 510(k)
Regulation Number
866.3980 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Panther Fusion Paraflu Assay is a parainfluenza multiplex nucleic acid assay designed for the detection and differentiation of parainfluenza viruses. This automated multiplex PCR test identifies human parainfluenza viruses from a single nasopharyngeal swab specimen.

The assay is performed using a fully-automated approach and provides results in approximately three hours. This device has received FDA 510(k) clearance and is classified as a class 2 medical device under regulation number 866.3980.

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. Sources consulted: Panther Fusion® Paraflu Assay - Hologic, Panther Fusion® Paraflu Assay | Resp Testing | Hologic® UK, Panther Fusion® Paraflu Assay | Testing | Hologic® New Zealand, Panther Fusion Paraflu Assay - BioCosm

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA 510(k) K172282 24 fields · synced Sep 22, 2026