YY/T 1304.2-2015 Translated English of Chinese Standard. (YYT 1304.2-2015, YY/T1304.2-2015, YYT1304.2-2015): Detection system of time-resolved fluoroimmunoassay - Part 2: Quantitative reagent (kit) for time-resolved fluoroimmunoassay [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 13 lug 2020 - 11 pagine This part of YY/T 1304 stipulates the terms and definitions, requirements and test methods, identification, labeling and instruction manuals, packaging, transportation and storage of quantitative reagent (kit) for time-resolved fluoroimmunoassay. This part applies to single-label time-resolved fluoroimmunoassay. |
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According to equation accuracy shall meet analyte Antibody applicable average value batch number batch of kits batches of reagent Blank limit body fluid components Calculate the average calibrator certified reference material certified reference substance coefficient of variation concentration level concentration of certified corresponding requirements device registration certificate Difference between batches document expiration date following methods GB/T Immunoassay including national reference international reference substance least 2 concentration main drafters manufacturer shall specify measurement results Medical device registration medically determined level meet the corresponding meet the requirements method of 5.2 month for stability national reference substance product's critical value Quantitative reagent reagent kits recovery rate reference substance including registration certificate number relative deviation Repeat the test result shall meet serum stability test standard deviation SD substance including national substance or international terms and definitions Test method testing according Thermal stability time-resolved fluoroimmunoassay analyzer Traceability validity period value or medically variation CV YY/T