HSA · registration DE0504438Ortho-Clinical VITROS Immunodiagnostic Products hs Troponin I Assay
- Registration number
- DE0504438
- Model name
- VITROS Immunodiagnostic Products hs Troponin I Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Calibrators; VITROS Immunodiagnostic Products hs Troponin I Low Control
- Model identifier
- 6844436; 6844437; 6900040
- Registration date
- May 05, 2020
- Source update date
- October 19, 2020
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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.
- Product owner address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.