YY/T 1217-2013 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of luteinizing hormone quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of luteinizing hormone (LH) based on the double-antibody sandwich method (hereinafter referred to as: LH kit). It includes using enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling and other labeling methods as capture antibodies, using microwell plates, tubes, magnetic particles, microbeads and plastic beads as carriers to coat the antibodies, and quantitatively determine LH immunoassay kit. This standard does not apply to: a) Various types of colloidal gold-labeled LH test papers; b) Various types of LH radioimmunoassay or immunoradiation kits labeled with radioactive isotopes such as 125I.

YY/T 1217-2013 Referenced Document

YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update