YY/T 1214-2013 Translated English of Chinese Standard. (YYT 1214-2013, YY/T1214-2013, YYT1214-2013): Human chorionic gonadotrophin quantitative labelling immunoassay kithttps://www.chinesestandard.net, 5 feb 2015 - 11 pagine This Standard specifies the classification, requirements, test method, marks, labels, operating instructions, packaging, transportation, and storage of the human chorionic gonadotrophin quantitative labelling immunoassay kit. |
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antibody Appearance and physical appropriate mathematical model areas of dose-response Between-analysis precision Between-batch precision calibrator chemiluminescent labelling chorionic gonadotrophin quantitative coefficient of variation Device Registration Certificate different areas dose-response curves enzyme labelling following contents freeze-dried gonadotrophin quantitative labelling HCG national standard HCG reagent kit hormone human chorionic gonadotrophin independent analysis IU/L kit’s labelling HCG reagent Linearity lowest detection limit manual operation reagent manufacturing enterprise material are set material shall comply measured results Measured value Medical Device Registration microbeads and plastic Minimum detection limit name and specifications national standard material Outer package period of validity plastic beads potency ratio precision The coefficient Product batch number Product name Product standard number provisions of 4.1 provisions of 4.5.2 quality control material quantitative detection quantitative labelling immunoassay reacting dose reagent kit buffer Registration Certificate Number response curve results of quality results shall comply Storage conditions value of quality variation CV Within-analysis precision YY/T