YY/T 1721-2020 Active Industry standards-Medicine

YY/T 1721-2020 Free thyroxine (FT4) testing kit

Publish Date: 2020-06-30 Implement Date: 2021-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1721-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2020-06-30

Implement Date: 2021-12-01

Pages: 12 pages

Scope

This standard specifies the classification, requirements, test methods, labeling, user's manual, packaging, transportation, and storage of free thyroxine determination kits (hereinafter referred to as FT4 kits).
This standard applies to immunoassay kits for the quantitative determination of free thyroxine (FT4) in vitro using methods such as enzyme labeling, (electro)chemiluminescence labeling, and (time-resolved) fluorescence labeling, based on the principle of double antibody sandwich assay or competitive assay.
This standard does not apply to:
a) Qualitative or semi-quantitative reagents (such as test strips, biochips, etc.) for the determination of human free thyroxine labeled with colloidal gold or other methods;
b) Various radioimmunoassay or immunoradiometric kits labeled with radioactive isotopes such as 125I;
c) Free thyroxine calibrators and quality control materials intended for separate sale, or calibrators and quality control materials in FT4 kits.