XPERT FLU/RSV XC ASSAY

XPERT FLU/RSV XC ASSAY is an FDA 510(k)-cleared medical device (K142045) 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 November 21, 2014. Regulation: 8.