Nano-Check Influenza A+B Test

Nano-Check Influenza A+B Test is an FDA 510(k)-cleared medical device (K252283) 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 14, 2026. Regulation: 8.