Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test

Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test is an FDA 510(k)-cleared medical device (K260754) manufactured by Assure Tech., 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 June 4, 2026. Regulation: 8.