Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is an FDA 510(k)-cleared medical device (K192376) 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 November 25, 2019. Regulation: 8.