Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is an FDA 510(k)-cleared medical device (K173932) 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 January 25, 2018. Regulation: 8.