YY/T 1583-2018 Active Industry standards-Medicine

YY/T 1583-2018 Folate testing kit (chemiluminescent immunoassay)

Publish Date: 2018-02-24 Implement Date: 2019-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1583-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2018-02-24

Implement Date: 2019-03-01

Pages: 7 pages

Scope

This standard specifies the requirements, test methods, marking, labeling, and user manuals, packaging, transportation, and storage for folic acid assay kits (chemiluminescence immunoassay) (hereinafter referred to as "kits"). This standard applies to kits used for quantitatively determining the folic acid content in human serum based on the principle of chemiluminescence immunoassay, including enzymatic and non-enzymatic chemiluminescence immunoassay kits using microwell plates, tubes, magnetic particles, microbeads, and plastic beads as carriers. This standard does not apply to: a) the determination of folic acid content in human red blood cells; b) folic acid calibrators and quality control products intended for separate sale; c) biochips based on the principle of chemiluminescence immunoassay.