BioFire Diagnostics BioFire Joint Infection Panel - HSA Registration DE0508701
Access comprehensive regulatory information for BioFire Diagnostics BioFire Joint Infection Panel in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508701 and owned by BioFire Diagnostics, LLC. The device was registered on November 29, 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.
BioFire Joint Infection Panel is a multiplexed nucleic-acid-based intended for simultaneous qualitative detection, identification of multiple bacterial, yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. The BioFire JI Panel is indicated as an aid in the diagnosis of specific agents of joint infection and results should be used in conjunction with other clinical and laboratory findings. The BioFire JI Panel is not intended to monitor treatment for joint infections.