T/GDMDMA 0028-2023 Active Group standards

T/GDMDMA 0028-2023 Heparin Binding Protein Assay Kit (Chemiluminescent Immunoassay)

Publish Date: 2023-05-26 Implement Date: 2023-05-26 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/GDMDMA 0028-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Laboratory medicine

Publish Date: 2023-05-26

Implement Date: 2023-05-26

Pages: 8 pages

Scope

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.