Nano-Check™ COVID-19 Antigen Test

Nano-Check™ COVID-19 Antigen Test is an FDA 510(k)-cleared medical device (K231187) manufactured by Nano-Ditech Corporation. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2024. Regulation: 8.