Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is an FDA 510(k)-cleared medical device (K173653) 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 May 1, 2018. Regulation: 8.