YY/T 1161-2009
Tumor Associated Antigen CA125 Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay) (English Version)
- Standard No.
- YY/T 1161-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1161-2009
- Scope
- This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of tumor-associated antigen CA125 quantitative determination reagents (kits). This standard applies to reagents (kits) for the determination of human tumor-associated antigen (CA125) 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 the requirements for calibrators and quality control materials in kits.
YY/T 1161-2009 history
- 2009 YY/T 1161-2009 Tumor Associated Antigen CA125 Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay)
