Hologic Panther™ Fusion System - HSA Registration DE0506516
Access comprehensive regulatory information for Hologic Panther™ Fusion System 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 DE0506516 and owned by Hologic, Inc.. The device was registered on December 24, 2021.
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 System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction. The Panther Fusion System supports processing of assays that utilize nucleic acid detection technologies such as Polymerase Chain Reaction (PCR), reverse transcription PCR (RT-PCR), real-time PCR, Transcription Mediated Amplification (TMA) and real-time TMA or other similar technologies. Sample processing and nucleic acid capture steps as well as TMA® assays are performed on the Panther System. The Panther® System with the Panther Fusion Module is referred to as the Panther Fusion System, which can be used to perform PCR and RT-PCR assays.