IVD Department quantitative C-reactive protein (CRP) testing - Vietnam Registration 240001075/PCBB-HN

The IVD quantitative C-reactive protein (CRP) test kit comprises the following components: (1) The quantitative C-reactive protein (CRP) test reagent (VITROS Chemistry Products wrCRP Reagent): For in vitro diagnostic use to quantitate the concentration of C-reactive protein (CRP) in serum and plasma (lithium heparin, sodium heparin) on the VITROS 4600 and VITROS 5600/XT 7600 automated biochemistry systems. CRP measurements are used to assess inflammatory disorders, tissue damage, and infections. CRP measurements by ultrasound support the identification and classification of individuals at risk for cardiovascular disease. When used in combination with traditional clinical laboratory assessment of acute coronary syndrome, CRP can be used as an independent prognostic marker for recurrent cases in patients with chronic coronary artery disease or acute coronary syndrome. (2) The quantitative C-reactive protein (CRP) calibrator kit (VITROS Chemistry Products Calibrator Kit 34): For in vitro diagnostic use to calibrate the VITROS 4600 and VITROS 5600/XT 7600 automated biochemistry systems when quantitating C-reactive protein (CRP).