Standard Number: YY/T 1250-2014(YY/T1250-2014)
Chinese:胰岛素定量标记免疫分析试剂盒
English:Insulin quantitative labelling immunoassay kit
Effective Date:2015-07-01
ICS:11.000
Standard Applicability:This standard applies to kits for quantitative determination of human insulin (h-INS) by double antibody sandwich method, including immunoassay kits for quantitative determination of human insulin by using enzyme labeling, (electro-) chemiluminescence labeling, (time-resolved) fluorescence labeling and other labeling methods as capture antibodies, and microtiter plates, tubes, magnetic particles, microbeads, plastic beads and other vectors as coated antibodies. This standard specifies the classification, requirements, test methods, marking, labeling, instructions for use, packaging, transportation and storage of insulin quantitative labeling immunoassay kit. This standard does not apply to: with colloidal gold or other methods of labeling of qualitative or semi-quantitative determination of human insulin reagents (such as: test strips, etc.); with 125I and other radioisotope labeling of various types of human insulin radioimmunoimmunoassay or immunoradiological kits.
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