YY/T 1249-2014: Translated English of Chinese Standard. (YYT 1249-2014, YY/T1249-2014, YYT1249-2014): Free prostate specific antigen quantitative labelling immunoassay kit
https://www.chinesestandard.net, 05 փտվ, 2015 թ. - 11 էջ
This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation, and storage of the free prostate specific antigen quantitative labelling immunoassay kit.
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Marks labels and instructions
Packaging transportation and storage
after-sales service organization antibody antigen quantitative labelling appropriate mathematical model areas of dose-response batches of products Between-batch precision chemiluminescence labelling coefficient of variation comparison materials comply with provisions concentration points control materials Device Registration Certificate Document dose-response curves enterprise or after-sales enzyme labelling following contents fPSA national free prostate specific freeze-dried component GB/T inspection results Instructions labelled ratio content labelling fPSA linear range manufacturing enterprise materials are set materials of free materials of prostate measured results measured value Medical Device Registration Minimum detection limit model for fitting name and specification national or international Packaging Period of validity potency ratio Product batch number product enterprise Product name Product standard number prostate specific antigen provisions of 4.1 quantitative labelling immunoassay range specified Reagent Registration Certificate Number results of control results shall comply series of calibrators specific antigen fPSA specific antigen quantitative Stability standard materials Storage conditions value of control variation CV Within-analysis precision