Standard Number: YY/T 1513-2017(YY/T1513-2017)
Chinese:C反应蛋白测定试剂盒
English:C-reactive protein testing kit
Effective Date:2018-04-01
ICS:11.100
Standard Applicability:This standard specifies the classification, requirements, test methods and marking, labeling, instructions for use, packaging, transportation and storage requirements for C-reactive protein assay kits. This standard applies to the antigen-antibody reaction as the basic principle of quantitative determination of blood samples C-reactive protein kit, including quantitative labeling immuno-methods (such as: (electro-)chemiluminescence) and immunoturbidimetric method (such as immunoturbidimetric transmission, latex-enhanced immunoturbidimetric method). This standard does not apply to the evaluation of C-reactive protein calibrators and quality control products and various types of colloidal gold labeled test strips.
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