DASH® SARS-CoV-2 & Flu A/B Test

DASH® SARS-CoV-2 & Flu A/B Test is an FDA 510(k)-cleared medical device (K241652) manufactured by Nuclein, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2024. Regulation: 8.