YY/T 1177-2010 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of cancer antigen CA72-4 quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human cancer antigen CA72-4 reagent (kit) [hereinafter referred to as "CA72-4 reagent (kit)"] based on the principle of chemiluminescence immunoassay. Including enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. This standard does not apply to: a) Tumor marker calibrators and tumor marker substance control substances intended to be sold separately. b) Biochip based on chemiluminescent immunoassay.

YY/T 1177-2010 Referenced Document

GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials

2010 YY/T 1177-2010 Cancer antigen CA72-4 quantitative detection reagent (kit).Chemiluminescent immunoassay