Ortho-Clinical VITROS Immunodiagnostic Products hs Troponin I Assay - HSA Registration DE0504438
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products hs Troponin I 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 DE0504438 and owned by Ortho-Clinical Diagnostics. The device was registered on May 05, 2020.
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For in vitro diagnostic use only. For the quantitative measurement of cardiac troponin I (cTnI) in human serum and plasma (heparin) using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Cardiac troponin I elevations are associated with myocardial damage, and in patients with acute coronary syndrome (ACS), troponin values are used to aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.