HSA · registration DE0509141Ortho-Clinical VITROS Chemistry Products wrCRP Reagent
- Registration number
- DE0509141
- Model name
- VITROS Chemistry Products Calibrator Kit 34; VITROS Chemistry Products wrCRP Reagent
- Model identifier
- 6907789; 6922333
- Registration date
- April 08, 2024
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
For in vitro diagnostic and laboratory professional use. VITROS Chemistry Products wrCRP Reagent quantitatively measures C-reactive protein (CRP) concentration in serum and plasma (lithium heparin, sodium heparin) using the automated VITROS 4600 Chemistry System and the VITROS 5600/XT 7600 Integrated Systems. Measurements of CRP are used in the evaluation of inflammatory disorders, tissue injury, and infections. CRP measurements with the Ultrasensitive Method aid in identification and stratification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndrome.
- Product owner address
- 100 Indigo Creek Drive, Rochester, New York, United States
- 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.