Ortho-Clinical VITROS Immunodiagnostic Products NT-proBNP II Assay - HSA Registration DE0504846
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products NT-proBNP II Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504846 and owned by Ortho-Clinical Diagnostics. The device was registered on August 19, 2020.
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For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of heart failure and for the risk stratification of acute coronary syndrome and heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with heart failure.