Standard Number: YY/T 1422-2016(YY/T1422-2016)
Chinese:血清妊娠相关血浆蛋白A检测试剂（盒）（定量标记免疫分析法）
English:Pregnancy-associated plasma protein A（PAPP-A）in serum detection reagents(kit)（quantitative labelling immunoassay）
Effective Date:2017-06-01
ICS:11.000
Standard Applicability:This standard specifies the requirements for serum pregnancy-related plasma protein A test reagent (kit) (quantitative labeling immunoassay), test methods, marking, labeling, instructions for use, packaging, transportation and storage requirements. This standard applies to carry out serum pregnancy-related plasma protein A quantitative test reagents (box) (quantitative labeling immunoassay). This standard does not apply to all kinds of colloidal gold labeled test strips, with 125I and other radioisotope labeling of all kinds of radioimmunoassay or immunoradiological kits.
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