Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots:Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial AssaysPanther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…