GB/T 43279.2-2023

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA

分子体外诊断检验 静脉全血检验前过程的规范 第2部分:分离基因组DNA

Standard Type
GBT
ICS
11.100.10
CCS
C30
Status
Active
Issue Date
2023-11-27
Implementation
2024-06-01
Centralized Committee
国家药监局
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

This standard specifies the pre-examination processes for isolating genomic DNA from venous whole blood used in molecular in vitro diagnostic testing. It is applied in clinical laboratories and healthcare settings to ensure the quality, integrity, and traceability of DNA samples before analysis, covering steps such as collection, transport, storage, and DNA extraction. The standard is critical for accurate downstream molecular diagnostics, including genetic testing, disease screening, and personalized medicine.

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.