QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY is an FDA 510(k)-cleared medical device (DEN140004) manufactured by Diagnostic Hybrids, Inc.. 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 12, 2014. Regulation: 8.