SEEGENE ANYPLEX II HSV-1/2 ASSAY

SEEGENE ANYPLEX II HSV-1/2 ASSAY is an FDA 510(k)-cleared medical device (K142156) manufactured by Seegene. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2015. Regulation: 8.