Flowflex Plus COVID-19 + Flu A/B Home Test

Flowflex Plus COVID-19 + Flu A/B Home Test is an FDA 510(k)-cleared medical device (K250377) manufactured by ACON Laboratories, 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 May 9, 2025. Regulation: 8.