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Medical Devices / Submissions and Approvals

Beckman Coulter Gains Clearance for Troponin Assay

June 29, 2018

The FDA granted 510(k) clearance for Beckman Coulter Diagnostics’ high-sensitivity troponin (hsTnl) assay for detecting troponin, a protein present in circulation during myocardial infarction.

The assay, which is unique due to its use of plasma and serum samples, allows laboratories to report results for clinical decision making in the acute-care setting.

The assay gives clinicians insights on cardiac conditions for patients with chest pain and helps them diagnose myocardial infarction.

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