WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is an FDA 510(k)-cleared medical device (K251563) manufactured by Wondfo USA Co, Ltd.. 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 19, 2025. Regulation: 8.