Standard Number: YY/T 1257-2015(YY/T1257-2015)
Chinese:游离人绒毛膜促性腺激素β亚单位定量标记免疫分析试剂盒
English:Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit
Effective Date:2016-01-01
ICS:11.000
Standard Applicability:This standard applies to the kit for quantitative determination of free human chorionic gonadotropin β subunit by double antibody sandwich method. It includes immunoassay kits for the quantitative determination of free human chorionic gonadotropin β subunit by using enzyme labeling, (electro)chemiluminescence labeling, (time-resolved) fluorescence labeling and other labeling methods as the capture antibody, and encapsulating the antibody in microtiter plates, tubes, magnetic particles, microbeads and plastic beads and other carriers. This standard specifies the classification of free human chorionic gonadotropin β subunit quantitative labeling immunoassay kit, test methods, marking, labeling, instructions for use, packaging, transportation and storage requirements. This standard does not apply to colloidal gold or other methods of labeling qualitative or semi-quantitative determination of free human chorionic gonadotropin β subunit reagents (such as: test strips, etc.); also does not apply to 125I and other radioisotopes labeled with various types of free human chorionic gonadotropin β subunit radioimmunoassay or immunoradiological kits.
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