
Binax, Inc.
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BINAXNOW PBP2A TEST, MODEL 890-000 is an FDA 510(k)-cleared medical device (K090301) manufactured by Binax, 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 April 13, 2010. Regulation: 8.