BioFire Diagnostics FilmArray Blood Culture Identification 2 (BCID2) Panel - HSA Registration DE0506525
Access comprehensive regulatory information for BioFire Diagnostics FilmArray Blood Culture Identification 2 (BCID2) Panel 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 DE0506525 and owned by BioFire Diagnostics, LLC. The device was registered on December 27, 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 BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. It is not intended to monitor treatment for bloodstream infection