GB/T 44830-2024

Active

General rules for determination of enzyme-linked immunosorbent assay kit

酶联免疫试剂盒检测通则

Standard Type
GBT
ICS
07.080
CCS
A40
Status
Active
Issue Date
2024-10-26
Implementation
2024-10-26
Centralized Committee
国家标准委
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

GB/T 44830-2024 provides the general technical requirements, test methods, and evaluation criteria for enzyme-linked immunosorbent assay (ELISA) kits used in clinical diagnostics, food safety testing, and environmental monitoring. It applies to manufacturers and laboratories in China to ensure the accuracy, reproducibility, and reliability of ELISA-based detection for antigens or antibodies in biological samples. The standard covers kit components, procedural steps, and performance validation, serving as a reference for quality control and regulatory compliance in medical and analytical testing contexts.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.