FilmArray BCID2 Control Panel M416

FilmArray BCID2 Control Panel M416 is an FDA 510(k)-cleared medical device (K200010) manufactured by Maine Molecular Quality Controls, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2020. Regulation: 8.