Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is an FDA 510(k)-cleared medical device (K151464) 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 July 27, 2015. Regulation: 8.