QUIDEL MOLECULAR RSV + HMPV ASSAY

QUIDEL MOLECULAR RSV + HMPV ASSAY is an FDA 510(k)-cleared medical device (K122189) manufactured by Quidel Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2013. Regulation: 8.