CorDx Tyfast COVID-19 Ag Rapid Test Rx

CorDx Tyfast COVID-19 Ag Rapid Test Rx is an FDA 510(k)-cleared medical device (K253882) manufactured by CorDx, 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 31, 2026. Regulation: 8.