OSOM INFLUENZA A&B TEST MODEL 190

OSOM INFLUENZA A&B TEST MODEL 190 is an FDA 510(k)-cleared medical device (K123182) manufactured by SEKISUI Diagnostics, LLC. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 4, 2012. Regulation: 8.