Heal-Check Rapid COVID-19 Antigen Self-Test

Heal-Check Rapid COVID-19 Antigen Self-Test is an FDA 510(k)-cleared medical device (K260095) 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 12, 2026. Regulation: 8.