YY/T 1177-2010 Translated English of Chinese Standard. (YYT 1177-2010, YY/T1177-2010, YYT1177-2010): Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassayhttps://www.chinesestandard.net, 5.2.2015 - 12 sivua This Standard specifies the classification, requirements, test methods, marking, labeling, instruction manual, packaging, transportation, and storage of the cancer antigen CA72-4 quantitative detection reagent (kit) (chemiluminescent immunoassay). |
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According to different according to Formula after-sales service organization automatic operation method batches of reagent Beijing Between-batch difference CA72-4 reagent CALCULATE the mean cancer antigen CA72-4 chemiluminescent immunoassay detection coefficient of variation concentrations of 10±2 condition of 37°C correlation coefficient detection according detection reagent kit Diagnostic System Standardization enzymatic and non-enzymatic Expiry date following contents GB/T immunoassay detection reagent instruction manual labeling of reagent’s least the following linear range manufacturing enterprise measured results Medical Clinical Testing Medical device registration methods to perform Minimum detection limit National Medical Clinical non-enzymatic chemiluminescent immunoassay OBTAIN the RLU package specifications PERFORM the detection period of validity Product name Product standard number quantitative detection reagent reagent kits recovery rate reference value relative deviation requirements of 4.3 requirements of 4.8 result shall comply RLU value corresponding standard deviation SD Storage conditions System Standardization Technical TAKE the expired test methods Traceability tumor marker Vitro Diagnostic System zero-concentration calibrator