Standard Number: YY/T 1252-2015(YY/T1252-2015)
Chinese:总IgE定量标记免疫分析试剂盒
English:Total IgE quantitative labelling immunoassay kit
Effective Date:2016-01-01
ICS:11.000
Standard Applicability:This standard applies to labeled immunoassay kits for quantitative determination of total IgE. Including enzyme labeling, chemiluminescent labeling and other labeling methods for the capture antibody, microtiter plates, tubes, magnetic particles, microbeads and plastic beads and other carriers encapsulated antibody, quantitative determination of total IgE immunoassay assay kit. This standard specifies the total IgE quantitative labeling immunoassay kit quality, test methods, instructions for use, signs, labels, packaging, transportation and storage requirements. This standard does not apply to colloidal gold labeled total IgE test strips and radioisotope labeled with 125I and other radioisotopes of various types of radioimmunoassay or immunoradioassay kits.
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