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YY/T 1513-2017 English PDF (YYT1513-2017)

YY/T 1513-2017 English PDF (YYT1513-2017)

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YY/T 1513-2017: C-reactive protein testing kit
This Standard specifies the classification, requirements, test method, marking, instructions for use, packaging, transportation and storage for C-reactive protein testing kits. This Standard applies to kits for quantitative determination of C-reactive protein in blood sample (hereinafter referred to as CRP kits) based on the basic principle of antibody-antigen reaction, including the labeling quantitation immune method [such as electrochemiluminescence] and immunoturbidimetry (such as turbidimetric immunoassay and latex particle-enhanced turbidimetric immunoassay). This Standard does not apply to: evaluate the calibration products and quality control products of C-reactive protein; all types of colloidal immunogold labeling test paper.

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