November 09, 2026
bioMérieux receives U.S. FDA 510(k) clearance for the latest versions of the BIOFIRE® FILMARRAY® Gastrointestinal Panels to enhance detection of gastrointestinal pathogens including norovirus
bioMérieux, a world leader in the field of in vitro diagnostics, today announces that the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel has obtained U.S Food and Drug Administration (FDA) 510(k) clearance and IVDR1 CE marking, and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid has received US FDA 510(k) clearance. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in about one hour.
