YY/T 1240-2014: Translated English of Chinese Standard. (YYT 1240-2014, YY/T1240-2014, YYT1240-2014): D-Dimer reagent (kit) [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 2015. 2. 5. - 15페이지
This Standard specifies the term and definition, requirements, test methods, symbols, labels and instructions, packing, transportation, and storage of D-Dimer quantitative detection reagent (kit).
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abnormal control plasma assessment and pre-test auxiliary diagnosis average value yi Batch number Beijing Between-batch difference clinical assessment coagulation coefficient of variation confidence interval D-D reagent D-dimer experiment D-Dimer reagent diagnosis of VTE Document experiment of D-dimer exterior packing Fibrinogen following requirements high-value abnormal control immunoturbidimetric D-Dimer instructions about D-Dimer labels and instructions linear regression lower than 95 manufacturing enterprise measured values Medical Device meet the following meet the requirements Negative predictive value non-suspicion normal control plasma obtained by repeated Packaging specifications packing shall provide packing The label pre-test probability predictive value NPV Pretest Possibility Product standard number PTP principle reagent instructions reference range Registration Certificate Number remove venous thrombus repeated tests requirements specified result shall comply sample size possesses selected in clinical significance Both incidences specified in 4.3 specified in GB/T specified storage conditions symbols specified Terms and definitions test results testing range Valid period variation CV VTE-suspected patient