BioFire Diagnostics’ Joint Infection Panel Gets De Novo Approval

BioFire Diagnostics’ BioFire Joint Infection (JI) in vitro diagnostic panel has won de novo approval from the FDA.

The multiplex assay can detect and identify multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes in synovial fluid from individuals who have a suspected joint infection.

The panel is intended for use with the company’s FilmArray polymerase chain reaction systems that integrate sample preparation, amplification, detection and analysis.