Standard Number: YY/T 1456-2016(YY/T1456-2016)
Chinese:铁蛋白定量检测试剂(盒)
English:Human Ferritin Quantitative Immunoassay reagents(kit)
Effective Date:2017-01-01
ICS:11.000
Standard Applicability:This standard specifies the requirements, test methods and marking, labeling, instructions for use, packaging, transportation and storage of ferritin quantitative detection reagents (kits). This standard applies to the antigen-antibody reaction as the basic principle of quantitative detection of ferritin reagents (kits) in blood samples or urine samples, including quantitative labeling immuno-methods [such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro-)chemiluminescence] and immunoturbidimetric methods (such as immunoturbidimetric transmission, latex-enhanced immunoturbidimetric assay, etc.). This standard does not apply to the evaluation of ferritin calibrators and quality control products.
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