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 immunoassay
https://www.chinesestandard.net, 5 Feb 2015 - 12 halaman
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 batches of reagent Beijing CA72-4 quantitative detection CA72-4 reagent CALCULATE the mean cancer antigen CA72-4 chemiluminescent immunoassay detection coefficient of variation Committee SAC/TC 136 concentrations of 10±2 correlation coefficient detection according enzymatic and non-enzymatic Expiry date following contents GB/T immunoassay detection reagent instruction manual labeling of reagent’s least the following linear range manual operation method manufacturing enterprise measured results Medical Clinical Testing Medical device registration methods to perform Minimum detection limit National Medical Clinical national standard material non-enzymatic chemiluminescent immunoassay package specifications PERFORM the detection period of validity principle of chemiluminescent Product name Product standard number quantitative detection reagent reagent kits recovery rate reference value registration certificate number 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 variation CV according