Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is an FDA 510(k)-cleared medical device (K161375) 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 17, 2016. Regulation: 8.