YY/T 1175-2010 Active Industry standards-Medicine

YY/T 1175-2010 Quantitative detection reagent(kit) for tumor markers—Chemiluminescent immunoassay

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1175-2010

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 10 pages

Scope

This standard specifies the terms and definitions, classification, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of quantitative assay reagents (kits) for tumor markers (chemiluminescence immunoassay) [hereinafter referred to as "reagents (kits)").
This standard applies to reagents (kits) used for quantitatively determining human tumor markers based on the principle of chemiluminescence immunoassay. These include enzymatic and non-enzymatic chemiluminescence immunoassay reagents (kits) carried on substrates such as microplates, tubes, magnetic particles, microbeads, and plastic beads.