COVID-19 Detect Rapid Self -Test

COVID-19 Detect Rapid Self -Test is an FDA 510(k)-cleared medical device (K251595) manufactured by InBios International, 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 October 11, 2025. Regulation: 8.