Alere BinaxNOW Influenza A & B Card 2, Alere Reader

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is an FDA 510(k)-cleared medical device (K181853) manufactured by Alere 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 7, 2018. Regulation: 8.