YY/T 1193-2011
Folicle stimulating hormone(FSH) quantitative immunoassay kit (chemiluminescent immunoassay) (English Version)
- Standard No.
- YY/T 1193-2011
- Language
- Chinese, Available in English version
- Release Date
- 2011
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1193-2011
- Scope
- This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of follicle-stimulating hormone (FSH) quantitative determination reagents (kits) (chemiluminescence immunoassay) products. This standard is applicable to the quantitative detection reagent (kit) of follicle-stimulating hormone (FSH) in human blood matrix or other liquid components based on the principle of chemiluminescence immunoassay (hereinafter referred to as "FSH reagent (kit)"). 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) Follitropin calibrators and follicle-stimulating hormone quality control products intended to be sold separately; b) Biochips based on chemiluminescence immunoassay.
YY/T 1193-2011 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 1193-2011 history
- 2011 YY/T 1193-2011 Folicle stimulating hormone(FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
