This standard specifies the requirements, test methods, labeling and instruction manuals, packaging, transportation and storage requirements for glycated albumin assay kits. This standard applies to the use of enzymatic kits for quantitative detection of glycated albumin in human serum or plasma, including reagents used on manual and semi-automatic, fully automatic biochemical analyzers. If the glycated albumin assay kit contains the albumin test component, the technical requirements of the albumin assay reagent refer to the corresponding standards.
Basic Data
Standard ID
YY/T 1578-2018 (YY/T1578-2018)
Description (Translated English)
Glycated albumin assay kit (enzymatic method)
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,866
Date of Issue
2018-02-24
Date of Implementation
2019-03-01
Quoted Standard
GB/T 29791.2
Regulation (derived from)
China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies requirements, test methods, labels, and instructions for use, packaging, transportation, and storage of glycated albumin assay kits. This standard applies to kits for the quantitative detection of glycated albumin in human serum or plasma by enzymatic methods, including reagents used on manual and semi-automatic, fully automatic biochemical analyzers. The glycated albumin assay kit contains, for example, an albumin test component, and the albumin assay reagent technical requirements refer to corresponding standards.
