YY/T 1214-2013
Human chorionic gonadotrophin quantitative labelling immunoassay kit (English Version)
- Standard No.
- YY/T 1214-2013
- Language
- Chinese, Available in English version
- Release Date
- 2013
- Published By
- Professional Standard - Medicine
- Status
- 2020-08
- Replace By
- YY/T 1214-2019
- Latest
- YY/T 1214-2019
- Scope
- This standard specifies the classification, requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of human chorionic gonadotropin quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of human chorionic gonadotropin (HCG) based on the double-antibody sandwich method (hereinafter referred to as: HCG kit). It includes using enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling and other labeling methods as capture antibodies, using microwell plates, tubes, magnetic particles, microbeads and plastic beads as carriers to coat the antibodies, and quantitatively determine HCG immunoassay kit. This standard does not apply to: a) colloidal gold-labeled HCG test strips; b) various types of HCG radioimmunoassay or immunoradiation kits labeled with radioactive isotopes such as 125I.
YY/T 1214-2013 Referenced Document
- YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1214-2013 history
- 2019 YY/T 1214-2019 Human chorionic gonadotrophin quantitative labelling immunoassay kit
- 2013 YY/T 1214-2013 Human chorionic gonadotrophin quantitative labelling immunoassay kit
