YY/T 1160-2009: Translated English of Chinese Standard. (YYT 1160-2009, YY/T1160-2009, YYT1160-2009): Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
https://www.chinesestandard.net, 5 feb. 2015 - 13 páginas
This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of carcinoembryonic antigen (CEA) quantitative determination reagent (kit) (chemiluminescent immunoassay).
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According to different accuracy added amount of inspection Amount of sampling Appearance applicable assignment batches of kits Beijing CALCULATE the mean calibrator Carcinoembryonic antigen CEA carriers CEA reagent chemiluminescent immunoassay coefficient of variation conducted contain at least deemed Difference between batches divided Equation ex-factory inspection fitting following contents greater including the amount inspection in batches inspection items instructions Instructions for analytical instructions of reagent labels least the following linear range lower limit luminescence phenomenon Main manual operation method manufacturing enterprise marks measurement procedure measurement results Medical Device microplates minimum detection limit ng/mL Note OBTAIN Packaging pass PERFORM the detection period of validity plastic beads principle Product name re-inspection reference relative Repeatability requirements results shall comply retained sample RLU values selected serum sample specificity standard deviation SD Storage TAKE terms and definitions test methods Thermal stability transportation type inspection variation CV vitro diagnostic Volume