FilmArray Respiratory Panel EZ (RP EZ)

FilmArray Respiratory Panel EZ (RP EZ) is an FDA 510(k)-cleared medical device (K152579) 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 October 2, 2016. Regulation: 8.