YY/T 1594-2018 Active Industry standards-Medicine

YY/T 1594-2018 Anti-TG quantitative labelling immunoassay kit

Publish Date: 2018-04-11 Implement Date: 2019-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1594-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2018-04-11

Implement Date: 2019-05-01

Pages: 8 pages

Scope

This standard specifies the scope of application, normative reference documents, classification, requirements, test methods, labels and user manuals, packaging, transportation, and storage for human anti-thyroglobulin antibody assay kits. This standard applies to labeled immunoassay kits for quantitative determination of human anti-thyroglobulin antibody (hereinafter referred to as Anti-TG kits), including those that use enzyme labeling, chemiluminescence labeling, and other labeling methods for quantitative determination of Anti-TG kits. This standard does not apply to: a) colloidal gold-labeled Anti-TG test strips; b) various radioimmunoassay or immunoradiometry kits labeled with radioactive isotopes such as 125I.