YY/T 1163-2009
Total Prostate Specific Antigen(t-PSA) Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay) (English Version)
- Standard No.
- YY/T 1163-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1163-2009
- Scope
- This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of total prostate-specific antigen (t-PSA) quantitative determination reagents (kits). This standard is applicable to quantitative determination reagents (kits) for the quantitative detection of total prostate-specific antigen (t-PSA) in human blood matrix or other body fluid components 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 1163-2009 history
- 2009 YY/T 1163-2009 Total Prostate Specific Antigen(t-PSA) Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay)
