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

Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack is an FDA 510(k)-cleared medical device (K152408) manufactured by Focus Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2015. Regulation: 8.