QUIDEL MOLECULAR INFLUENZA A + B ASSAY

QUIDEL MOLECULAR INFLUENZA A + B ASSAY is an FDA 510(k)-cleared medical device (K131728) 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 August 28, 2013. Regulation: 8.