Hologic Panther Fusion® Flu A/B/RSV Assay - HSA Registration DE0508119
Access comprehensive regulatory information for Hologic Panther Fusion® Flu A/B/RSV Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0508119 and owned by Hologic, Inc.. The device was registered on May 24, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. This assay is intended to aid in the differential diagnosis of influenza A virus, influenza B virus and RSV infections in humans and is not intended to detect influenza C virus infections. Negative results do not preclude influenza A virus, influenza B virus or RSV infections and should not be used as the sole basis for treatment or other management decisions. This assay is designed for use on the Panther Fusion system.