Simplexa VZV Direct, Simplexa VZV Positive Control Pack

Simplexa VZV Direct, Simplexa VZV Positive Control Pack is an FDA 510(k)-cleared medical device (K190219) manufactured by Diasorin Molecular, LLC. 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, 2019. Regulation: 8.