YY/T 1250-2014 Active Industry standards-Medicine

YY/T 1250-2014 Insulin quantitative labelling immunoassay kit

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1250-2014

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 8 pages

Scope

This standard specifies the classification, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of quantitative labeled immunoassay kits for insulin.
This standard applies to kits used for quantitatively measuring human insulin (hINS) based on the principle of a double antibody sandwich assay (hereinafter referred to as INS kits). These kits include those using enzyme-labeled, (electro)chemiluminescence-labeled, and (time-resolved) fluorescence-labeled methods for capture antibodies, as well as those using carriers such as microplates, tubes, magnetic particles, microbeads, and plastic beads for coating antibodies, for quantitatively measuring human insulin in immunoassays.