Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is an FDA 510(k)-cleared medical device (K150962) manufactured by Focus Diagnostics. 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 27, 2015. Regulation: 8.