BioFire RP2.1/RP2.1plus Control Panel M441

BioFire RP2.1/RP2.1plus Control Panel M441 is an FDA 510(k)-cleared medical device (K202196) 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 June 23, 2021. Regulation: 8.