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510(k) for Chiron Diagnostics:

This article was originally published in Clinica

Executive Summary

Chiron Diagnostics has received FDA clearance for its ACS:180 Troponin I assay. The fully-automated cardiac marker measures the quantity of troponin I, one of the three polypeptides which make up the cardiac troponin complex (cTnl), in serum and plasma. cTnl is not normally found in circulation and any level of this complex in the blood indicates some form of myocardial damage.





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