This Standard specifies the determination principle, requirements, test method, mark, label, instructions, packaging, transport and storage, etc. of glucose assay kit (enzymic method). This Standard uses glucose hexokinase and oxidase method to measure the kit which is used for the quantitative analysis of glucose concentration for serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical examination.
Basic Data
Standard ID
YY/T 1200-2013 (YY/T1200-2013)
Description (Translated English)
Glucose assay kit (Enzymic method)
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
9,937
Quoted Standard
GB/T 191
Regulation (derived from)
State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the principles for measuring glucose assay kit (enzymatic), requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to hexokinase and glucose oxidase assa
