YY/T 1216-2013: Translated English of Chinese Standard. (YYT 1216-2013, YY/T1216-2013, YYT1216-2013): Alpha-fetoprotein quantitative labelling immunoassay kit
This Standard specifies the classification, requirements, test method, marks, labels, operating instructions, packaging, transportation, and storage of the alpha-fetoprotein quantitative labelling immunoassay kit.
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according AFP kits Alpha-fetoprotein quantitative labelling antibody batch number Between-analysis precision Between-batch precision CALCULATE the coefficient CALCULATE the mean chemiluminescent coefficient of variation contact information DETECT at least Device Registration Certificate different concentrations dosage-reaction Equation external package following contents higher than 20.0 inspection methods inspection results labelling methods least 10 normal linear range magnetic particles manual operation Manufacturing enterprise’s name materials with different mean of measured measured results Measured value Medical Device Registration microbeads microplates Minimum detection limit model and specifications national standard materials normal serum operating instructions operation method period of validity plastic beads Product name Product standard number production address provisions of 4.1 quality control material quality control products quantitative detection quantitative labelling immunoassay reagent registered address Registration Certificate Number relative deviation requirements results shall comply sample Specificity DETECT specified standard deviation SD Storage condition test quality control Thermal stability transportation value of quality variation of test Within-analysis precision YY/T