AMIPLIVUE HSV 1&2 ASSAY

AMIPLIVUE HSV 1&2 ASSAY is an FDA 510(k)-cleared medical device (K140029) manufactured by Quidel Corporation. 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 25, 2014. Regulation: 8.