www.fdanews.com/articles/189361-quidel-gains-ce-mark-for-high-sensitivity-troponin-i-test
Quidel Gains CE Mark for High-Sensitivity Troponin I Test
November 30, 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.