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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › Quidel Gets CE Mark for Near-Patient High-Sensitivity Troponin Test

Quidel Gets CE Mark for Near-Patient High-Sensitivity Troponin Test

Nov 29, 2018

NEW YORK (360Dx) – Quidel announced today it has received CE marking for a near-patient diagnostic assay for determining troponin I levels as an aid in diagnosing myocardial infarction.

The TriageTrue High Sensitivity Troponin I Test is a single-use fluorescence immunoassay that detects a subunit of the troponin complex released by heart muscle cells after a myocardial infarction. The test is run using whole blood or plasma specimens that have been anticoagulated with EDTA on the Quidel Triage Meter Pro instrument.

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