YY/T 1214-2013 Replaced Industry standards-Medicine

YY/T 1214-2013 Human chorionic gonadotrophin quantitative labelling immunoassay kit

Publish Date: 2013-10-21 Implement Date: 2014-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1214-2013

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2013-10-21

Implement Date: 2014-10-01

Pages: 8 pages

Scope

This standard specifies the classification, requirements, test methods, marking, labels and user manuals, packaging, transportation, and storage of quantitative labeled immunoassay kits for human chorionic gonadotropin (HCG).
This standard applies to kits that quantitatively measure HCG using the principle of a double antibody sandwich assay (hereinafter referred to as HCG kits). These include immunoassay kits that use enzyme-labeled, (electro) chemiluminescence-labeled, or (time-resolved) fluorescence-labeled methods for capture antibodies, and use microplates, tubes, magnetic particles, microbeads, and plastic beads as carriers for antibody coating to quantitatively measure HCG.
This standard does not apply to:
a) Colloidal gold-labeled HCG test strips;
b) Various HCG radioimmunoassay or immunoradiometric kits labeled with radioactive isotopes such as 125I.