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Diagnostics
Company launches FDA-cleared high sensitivity Troponin I assay
September 5th, 2004
Dade Behring (DADE) announced its Stratus CS Cardiac Troponin I assay is the first Troponin test cleared by the U.S. Food and Drug Administration as high sensitivity. This high sensitivity designation is possible because of the assay's high level of precision, meeting the European Society of Cardiology/American College of Cardiology recommendation of less than 10% coefficient of variation at the 99th percentile of normal. It is for use on Dade Behring's Stratus CS Acute Care Diagnostic System. The assay is cleared for the measurement of cardiac troponin I to aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with acute...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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