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Instrumentation Laboratory CO
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HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM is an FDA 510(k)-cleared medical device (K110031) manufactured by Instrumentation Laboratory CO. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 23, 2011. Regulation: 8.