XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) is an FDA 510(k)-cleared medical device (K120911) manufactured by Cepheid. 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 17, 2012. Regulation: 8.