Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack

Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack is an FDA 510(k)-cleared medical device (K142365) 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 December 4, 2014. Regulation: 8.