Simplexa COVID-19 & Flu A/B Direct

Simplexa COVID-19 & Flu A/B Direct is an FDA 510(k)-cleared medical device (K220963) 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 March 16, 2023. Regulation: 8.