bioMérieux Receives the US FDA’s 510(k) Clearance for BIOFIRE FILMARRAY GI1.1 Panels to Detect Gastrointestinal Pathogens

Shots: bioMérieux has received the US FDA’s 510(k) clearance for its BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel & GI1.1 Panel Mid, with the GI1.1 Panel also receiving CE marking under the IVDR The PCR-based panels detect 22 & 11 common gastroenteritis-causing bacteria, viruses & parasites, respectively, from a single stool sample in ~1hr. with ~2min. hands-on time, on the BIOFIRE FILMARRAY 2.0 & TORCH systems The updated versions include a redesigned norovirus GI/GII assay & a software-based improvement for Campylobacter detection to strengthen specificity; the GI1.1 Panel will be deployed globally, while the Mid panel will initially be available in the US Ref: bioMérieux  |   Image: bioMérieux  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post bioMérieux Receives the US FDA’s 510(k) Clearance for BIOFIRE FILMARRAY GI1.1 Panels to Detect Gastrointestinal Pathogens appeared first on PharmaShots.