Aptima Herpes Simplex Viruses 1 & 2 Assay

Aptima Herpes Simplex Viruses 1 & 2 Assay is an FDA 510(k)-cleared medical device (K162673) manufactured by Hologic, 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 June 14, 2017. Regulation: 8.