Flowflex® Plus COVID-19 Home Test

Flowflex® Plus COVID-19 Home Test is an FDA 510(k)-cleared medical device (K233373) 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 April 18, 2024. Regulation: 8.