FilmArray RP2/RP2plus Control Panel

FilmArray RP2/RP2plus Control Panel is an FDA 510(k)-cleared medical device (K173171) 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 November 23, 2017. Regulation: 8.