Standard Number: YY/T 1177-2010(YY/T1177-2010)
Chinese:癌抗原CA72-4定量测定试剂（盒）化学发光免疫分析法
English:Cancer antigen CA72-4 quantitative detection reagent(kit)-Chemiluminescent immunoassay
Effective Date:2012-06-01
ICS:11.000
Standard Applicability:This standard specifies the classification, requirements, test methods, marking, labeling, instructions for use, packaging, transportation and storage of reagents (kits) for quantitative determination of human cancer antigen CA72-4 (chemiluminescence immunoassay). This standard applies to chemiluminescence immunoassay as the principle of quantitative determination of human cancer antigen CA72-4 reagents (kits), including microtiter plates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (kits). This standard does not apply to: a) Tumor marker calibrators and tumor marker controls intended to be sold separately. b) Biochips based on the principle of chemiluminescent immunoassay. c) Biochips based on the principle of chemiluminescent immunoassay. d) Biochips intended to be sold separately.
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