BioFire Diagnostics FilmArray Instruments - HSA Registration DE0501954
Access comprehensive regulatory information for BioFire Diagnostics FilmArray Instruments 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 DE0501954 and owned by BioFire Diagnostics, LLC. The device was registered on July 27, 2018.
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 FilmArray instrument is an automated in vitro diagnostic device intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical samples. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray software automatically determines the results and provides a test report.