YY/T 1176-2010
Cancer antigen CA15-3 quantitative detection reagent (kit).Chemiluminescent immunoassay (English Version)
- Standard No.
- YY/T 1176-2010
- Language
- Chinese, Available in English version
- Release Date
- 2010
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1176-2010
- Scope
- This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of cancer antigen CA15-3 quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of cancer antigen CA15-3 reagent (box) [hereinafter referred to as "CA15-3 reagent (box)"] 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 1176-2010 history
- 2010 YY/T 1176-2010 Cancer antigen CA15-3 quantitative detection reagent (kit).Chemiluminescent immunoassay
