This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of free human chorionic gonadotropin beta subunit quantitative labeling immunoassay kits. This standard is applicable to kits for the quantitative determination of free human chorionic gonadotropin β subunit based on the double-antibody sandwich method. This standard does not apply to: a) reagents for qualitative or semi-quantitative determination of free human chorionic gonadotropin beta subunits labeled with colloidal gold or other methods (such as test strips, etc.); b) labeled with Class I radioactive isotopes Various types of free human chorionic gonadotropin beta subunit radioimmunoassay or immunoradiation kits.
YY/T 1257-2015 history
2015YY/T 1257-2015 Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit