YY/T 1163-2009 Translated English of Chinese Standard. (YYT 1163-2009, YY/T1163-2009, YYT1163-2009): Total Prostate Specific Antigen (t-PSA) Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)https://www.chinesestandard.net, 2015. 2. 5. - 14페이지 This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (chemiluminescent immunoassay). |
자주 나오는 단어 및 구문
6ng/mL to repeatedly According to different according to GB/T after-sales service organization amount of inspection Amount of sampling applied t-PSA calibrator batches of reagent Beijing blood matrix CALCULATE the mean chemiluminescence immunoassay reagent coefficient of variation component of reagent concentration of total detection reagent kit Deviation Bn device registration certificate diluent Equimolar reactivity factory-exit inspection following contents free PSA inspection items item unqualified least the following linear range lower limit M+2SD manufacturing enterprise measurement procedure measurement results methods of 6.3 minimum detection limit ng/mL allowed period of validity Product batch number Product name Product standard number proportion of free prostate specific antigen PSA and PSA-ACT PSA-ACT complex quantitative detection reagent reactivity of paired reagent kits registration certificate number requirements of 5.3 results shall comply RLU value serum sample Shanghai specific antigen t-PSA standard deviation SD terms and definitions test methods theoretical concentration total prostate specific variation CV according zero-concentration calibrator