CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is an FDA 510(k)-cleared medical device (K240728) 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 June 20, 2024. Regulation: 8.