ALERE INFLUENZA A & B TEST

ALERE INFLUENZA A & B TEST is an FDA 510(k)-cleared medical device (K133637) manufactured by Alere Scarborough, Inc D/B/A Binax, 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 December 17, 2013. Regulation: 8.