YY/T 1249-2014 Active Industry standards-Medicine

YY/T 1249-2014 Free prostate specific antigen 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 1249-2014

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, testing methods, marking, labeling, user manuals, packaging, transportation, and storage of quantitative immunoassay kits for free prostate-specific antigen (fPSA).
This standard applies to kits that quantitatively measure free prostate-specific antigen (fPSA) using the principle of a double-antibody sandwich assay (hereinafter referred to as fPSA kits). These include immunoassay kits that use enzyme-labeled, (electro)chemiluminescence-labeled, and (time-resolved) fluorescence-labeled methods for capture antibodies, and microplates, tubes, magnetic particles, microbeads, and plastic beads as coating antibodies to quantitatively measure fPSA.