QuidelOrtho
The FDA has granted QuidelOrtho 510(k) clearance for the VITROS hs Troponin I Reagent Pack. The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).
The VITROS Systems are built on dry-slide, MicroWell and INTELLICHECK Technologies designed to deliver workflow efficiency, reliability and quality clinical results in laboratories worldwide.
The commercial rollout for U.S. laboratories operating VITROS Systems will begin later this year.
