GB/T 26124-2011

Active

In vitro diagnostic reagent(kit) for clinical chemistry

临床化学体外诊断试剂(盒)

Standard Type
GBT
ICS
11.100
CCS
C44
Status
Active
Issue Date
2011-05-12
Implementation
2011-11-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the classification, requirements, test methods, labeling, packaging, transportation, and storage for in vitro diagnostic reagents (kits) used in clinical chemistry. It applies to reagents and kits that measure chemical analytes in human body fluids, such as blood or urine, within hospital laboratories and clinical testing facilities. The standard ensures product quality, safety, and consistency for diagnostic applications like monitoring organ function or metabolic disorders.

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.