Ortho-Clinical VITROS Chemistry Products wrCRP Reagent - HSA Registration DE0509141
Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products wrCRP Reagent 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 DE0509141 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on April 08, 2024.
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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.