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FDA clears Roche's automated D-Dimer test:

This article was originally published in Clinica

Executive Summary

Roche Diagnostics has received US FDA 510(k) marketing clearance to use its D-Dimer assay, for excluding a diagnosis of deep vein thrombosis (DVT) and pulmonary embolism, on an automated clinical chemistry platform. The assay can be run on the firm's Roche/Hitachi and Cobas Integra chemistry analysers and can produce a result in just 10 minutes. DVT affects around 1 million people in the US each year.

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