ID NOW COVID-19 2.0

ID NOW COVID-19 2.0 is an FDA 510(k)-cleared medical device (K221925) 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 August 9, 2023. Regulation: 8.