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In Brief: Biosite Diagnostics Triage

This article was originally published in The Gray Sheet

Executive Summary

Biosite Diagnostics Triage: Point-of-care cardiac test panel for rapid diagnosis of heart attacks gains additional 510(k) clearances for quality control, calibration verification and Triage meter components, clearing the way for a product launch in early spring pending completion of internal validation of the manufacturing process, the firm says. San Diego-based Biosite had gained clearance for CK-MB, myoglobin and troponin I measurement in October ("The Gray Sheet" Oct. 20, In Brief), but was awaiting the additional clearances prior to marketing. The Triage meter is used in tandem with the panel to quantitatively measure levels of the target analytes...



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