FilmArray Respiratory Panel 2 (RP2)

FilmArray Respiratory Panel 2 (RP2) is an FDA 510(k)-cleared medical device (K170604) 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 May 29, 2017. Regulation: 8.