YY/T 1213-2013 Replaced Industry standards-Medicine

YY/T 1213-2013 Follicle stimulating hormone 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 1213-2013

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, labeling, user's manual, packaging, transportation, and storage of quantitative labeled immunoassay kits for follicle-stimulating hormone (FSH).
This standard applies to kits that quantitatively measure FSH based on the principle of a double antibody sandwich assay (hereinafter referred to as FSH 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 FSH.
This standard does not apply to:
a) Colloidal gold-labeled FSH test strips;
b) Various FSH radioimmunoassay or immunoradiometry kits labeled with radioactive isotopes such as 125I.