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In Brief: American Biogenetic Sciences

This article was originally published in The Gray Sheet

Executive Summary

American Biogenetic Sciences: Submits 510(k) for its TpP (Thrombus Precursor Protein) test, intended for use as an aid in monitoring the efficacy of anticoagulant (heparin) therapy and assessing the risk of thrombosis. The test quantitates soluble fibrin polymers, a marker of active thrombosis. ABS has licensed its TpP technology to Roche and Abbott for inclusion on their immunoassay systems, which requires additional 510(k) clearances...



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