SCoV-2 Ag Detect Rapid Test

SCoV-2 Ag Detect Rapid Test is an FDA 510(k)-cleared medical device (K233358) 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 August 22, 2024. Regulation: 8.