Standard Number: YY/T 1176-2010(YY/T1176-2010)
Chinese:癌抗原CA15-3定量测定试剂（盒）化学发光免疫分析法
English:Cancer antigen CA15-3 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 the reagent (kit) for quantitative determination of cancer antigen CA15-3 (chemiluminescence immunoassay). This standard applies to chemiluminescence immunoassay as the principle of quantitative determination of cancer antigen CA15-3 reagent (kit). Including microtiter plates, tubes, magnetic particles, microbeads and plastic beads as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay determination 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 chemiluminescence immunoassay.
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