ALERE I INFLUENZA A & B

ALERE I INFLUENZA A & B is an FDA 510(k)-cleared medical device (K141520) 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 June 12, 2014. Regulation: 8.