HSA · registration DE0504846Ortho-Clinical VITROS Immunodiagnostic Products NT-proBNP II Assay
- Registration number
- DE0504846
- Model name
- VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack; VITROS Immunodiagnostic Products NT-proBNP II Calibrators; VITROS Immunodiagnostic Products NT-proBNP II Controls
- Model identifier
- 6844452; 6844453; 6844507
- Registration date
- August 19, 2020
- Source update date
- December 02, 2020
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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.
- 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.