YY/T 1664-2019 Active Industry standards-Medicine

YY/T 1664-2019 Parathyroid hormone testing kit

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1664-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2019-07-24

Implement Date: 2020-08-01

Pages: 8 pages

Scope

This standard specifies the classification, requirements, test methods, labels and user manuals, packaging, transportation, and storage of parathyroid hormone (PTH) assay kits. This standard applies to immunoassay kits that quantitatively determine the full-length parathyroid hormone (1–84) using the double antibody sandwich assay principle, including those using enzyme-labeled, (electro) chemiluminescence-labeled, and (time-resolved) fluorescence-labeled methods. This standard does not apply to: semi-quantitative assays of the full-length parathyroid hormone (1–84) labeled with colloidal gold or other methods (such as test strips); and various radioimmunoassay or immunoradiometric assay kits labeled with radioactive isotopes such as 125I for parathyroid hormone.