T/GDMDMA 0028-2023 Active

Scope: This document specifies the requirements, test methods, markings, labels, and user manuals, as well as packaging, transportation, and storage for heparin-binding protein assay kits (chemiluminescence immunoassay) (hereinafter referred to as HBP kits). This document applies to kits used for quantitatively determining the content of heparin-binding protein in human blood based on the principle of chemiluminescence immunoassay, including enzymatic and non-enzymatic chemiluminescence immunoassay kits with carriers such as microplates, tubes, and magnetic particles, as well as manual and automated instrument operation methods. This document does not apply to heparin-binding protein calibrators and quality control products intended for separate sale. Main technical content: It mainly specifies the scope, normative references, terms and definitions, requirements, test methods, markings, labels, user manuals, packaging, transportation, and storage.