FINDER Flu A&B/SARS-CoV-2 Test

FINDER Flu A&B/SARS-CoV-2 Test is an FDA 510(k)-cleared medical device (K252269) manufactured by Baebies, 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 March 29, 2026. Regulation: 8.