Instrumentation Laboratory Receives FDA Clearance For HemosIL RecombiPlasTin 2G Assay

Instrumentation Laboratory (IL) announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for HemosIL(R) RecombiPlasTin 2G. This new product is the second generation of HemosIL RecombiPlasTin, one of the most widely used Prothrombin Time (PT) reagents in the world. HemosIL RecombiPlasTin 2G is performed for pre-surgical screening to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy. [click link for full article]

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Filed under: Cardiovascular on September 26th, 2007