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Medical Devices / Submissions and Approvals

Quidel Gains CE Mark for High-Sensitivity Troponin I Test

Dec. 3, 2018

Quidel earned the CE Mark for its TriageTrue  near-patient diagnostic troponin assay, used for diagnosing heart attacks.

The single-use fluorescence immunoassay detects a subunit of the troponin complex that heart muscle cells release after a myocardial infarction.

The test uses whole blood or plasma specimens that have been anticoagulated with EDTA on Quidel’s Triage Meter Pro device.

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