YY/T 1162-2009
Alpha-fetoprotein quantitative detection reagent(Kit) (Chemiluminescent Immunoassay) (English Version)
- Standard No.
- YY/T 1162-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1162-2009
- Scope
- This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of alpha-fetoprotein (AFP) quantitative determination reagents (kits). This standard is applicable to quantitative determination reagents (boxes) for the quantitative detection of alpha-fetoprotein (AFP) 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 1162-2009 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
YY/T 1162-2009 history
- 2009 YY/T 1162-2009 Alpha-fetoprotein quantitative detection reagent(Kit) (Chemiluminescent Immunoassay)
