Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack is an FDA 510(k)-cleared medical device (K202755) 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 4, 2022. Regulation: 8.