BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray® Torch, the New High Throughput FilmArray® System with FilmArray® Respiratory Panel
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has submitted the FilmArray® Torch to the U.S. Food and Drug Administration (FDA) for special1 510(k) clearance for use with the FilmArray® Respiratory Panel (RP).
bioMérieux introduces GENE-UP®, a new molecular diagnostic solution for food pathogen detection jointly developed with BioFire
New generation PCR system benefits from the combined expertise of bioMérieux, world leader in microbiological food safety control and of BioFire, reputed for its know-how in molecular biology
bioMérieux and Illumina Enter Agreement to Co-Develop a Next-Generation Sequencing Solution for Epidemiological Monitoring of Bacterial Infections
Marcy l’Etoile, France – San Diego, California, United States – November 18, 2014 – bioMérieux, a world leader in the field of in vitro diagnostics, and Illumina, a world leader in genomics, announced they have signed an exclusive agreement to launch a next-generation sequencing (NGS) epidemiology solution for service labs. The two companies will jointly develop applications for microbiology sequencing technologies within a four-year renewable period.
Marcy l’Etoile (France) - October 27, 2014 - BioFire Defense, LLC of Salt Lake City, UT announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for its commercial FilmArray® Ebola test (BioThreat-E test™).