Healgen Rapid COVID-19 Antigen Test

Healgen Rapid COVID-19 Antigen Test is an FDA 510(k)-cleared medical device (K232377) manufactured by Healgen Scientific,, 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 April 18, 2024. Regulation: 8.