US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test. The application included positive ...
Tags: Biofire, FDA Clearance
BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel. The BCID panel provides automatic results for the most common infectious causes ...
Tags: Biofire, Filmarray Blood Culture
The US Patent and Trademark Office (USPTO) has granted patent no. 8,394,608 to BioFire Diagnostics' patent application covering the FilmArray system. The patent covers methods for sample preparation and two-step multiplex polymerase chain ...
Tags: BioFire, FilmArray system, clinical labs