YY/T 1218-2013: Translated English of Chinese Standard. (YYT 1218-2013, YY/T1218-2013, YYT1218-2013): Thyroid-stimulating hormone quantitative labelling immunoassay kit
https://www.chinesestandard.net, 5 févr. 2015 - 11 pages
This Standard specifies the classification, requirements, test methods, marks, labels, instructions, packaging, transportation, and storage of the thyroid-stimulating hormone quantitative labelling immunoassay kit.
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antibody Appearance and physical appropriate mathematical model areas of dose-response batches of products Between-analysis precision calibration product chemiluminescent labelled coefficient of variation contain the following control measured results Device Registration Certificate different areas dose-response curves external package following contents hormone quantitative labelling independent analysis inspection results IU/L labelled TSH labelling methods Linearity of dose-response lower than 200 lowest detection limit manual operation mathematical model fitting measured value Medical Device Registration microbeads Minimum detection limit name and specification national standard product Period of validity physical examination plastic beads potency ratio Precision between-batches Product batch number Product name Product standard number products are set products shall comply provision of 4.5.2 provisions of 4.1 quality control products quantitative labelling immunoassay reacting dose Registration Certificate Number results of quality results shall comply standard deviation SD Storage conditions three quality control Thyroid-stimulating hormone quantitative TSH national standard value of quality variation CV Within-analysis precision YY/T