CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is an FDA 510(k)-cleared medical device (K251604) manufactured by Access Bio, 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 August 21, 2025. Regulation: 8.