FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is an FDA 510(k)-cleared medical device (K160459) manufactured by Biofire Diagnostics, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2016. Regulation: 8.