YY/T 1257-2015 Active Industry standards-Medicine

YY/T 1257-2015 Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1257-2015

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 8 pages

Scope

This standard specifies the classification, requirements, test methods, marking, labeling, user's manual, packaging, transportation, and storage of quantitative labeled immunoassay kits for free human chorionic gonadotropin (hCG) β-subunit.
This standard applies to kits used to quantitatively determine the free human chorionic gonadotropin (hCG) β-subunit based on the principle of a double antibody sandwich assay.
This standard does not apply to:
a) Qualitative or semi-quantitative assays for free human chorionic gonadotropin (hCG) β-subunit labeled with colloidal gold or other methods (such as test strips, etc.);
b) Various radioimmunoassay or immunoradiometric kits for free human chorionic gonadotropin (hCG) β-subunit labeled with radioactive isotopes such as 125I.