BinaxNOW™ COVID-19 Antigen Self Test

BinaxNOW™ COVID-19 Antigen Self Test is an FDA 510(k)-cleared medical device (K243518) manufactured by Abbott Diagnostics Scarborough, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2025. Regulation: 8.