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See Chinese contents: YY/T 1213-2013 YY/T 1213-2013: Follicle stimulating hormone quantitative labelling immunoassay kit
This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the follicle stimulating hormone quantitative labelling immunoassay kit. This standard is applicable to follicle stimulating hormone (FSH) kit that is quantitatively determined and based on the principle of double antibody sandwich method. It includes the FSH immunoassay kit of quantitative determination by using enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence labelling and other labelling methods as the capture antibodies; and taking micro-plates, tubes, magnetic particles, micro-beads and plastic beads and others as the carrier coated antibodies. This standard does not apply to: a) Colloidal gold labeled FSH test strip; b) Various types of FSH radio-immunity or IRMA kit labeled with 125I and other radioactive isotopes.
