www.fdanews.com/articles/192117-ortho-clinical-gains-ce-mark-for-cardiac-assay
Ortho Clinical Gains CE Mark for Cardiac Assay
July 24, 2019
Ortho Clinical Diagnostics has received the CE Mark for an improved version of its Vitros NT-proBNP II product, a diagnostic used to identify heart failure.
The assay is also designed for risk stratification — grouping patients based on their risk and rising risk — of acute coronary syndrome and heart failure.
The enhanced version of the assay has improved assay quality through the use of monoclonal antibodies and an enhanced resistance to potential interferences.