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In Brief: Boehringer Mannheim

This article was originally published in The Gray Sheet

Executive Summary

Boehringer Mannheim: Gains 510(k) clearance from FDA for the Cardiac T Rapid Assay, a point-of-care version of its troponin-T test. Boehringer has marketed a troponin-T assay -- used to help diagnose myocardial infarction -- on its ES 300 ELISA immunoassay system since June 1994. The Cardiac T Rapid Assay has been sold in Europe as the Trop T Rapid Assay since September 1994...

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