Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is an FDA 510(k)-cleared medical device (K183223) 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 December 18, 2018. Regulation: 8.