YY/T 1200-2024: Glucose assay kit (Enzymic method)

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Scope

This document specifies the requirements, labeling and instructions for use, packaging,
transportation and storage of glucose assay kits (enzymatic method), and describes the
corresponding test methods.
This document applies to determination of assay kits by hexokinase method and glucose
oxidase method, which are used in clinical tests to quantitatively analyze the glucose
concentration in body fluids such as serum, plasma, urine, and cerebrospinal fluid.

Basic Data

Standard ID	YY/T 1200-2024 (YY/T1200-2024)
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	11.100.10
Word Count Estimation	9,925
Date of Issue	2024-02-07
Date of Implementation	2025-03-01
Older Standard (superseded by this standard)	YY/T 1200-2013
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements, labels and instructions for use, packaging, transportation and storage of glucose determination kits (enzymatic method), and describes the corresponding test methods. This document is applicable to the hexokinase method and glucose oxidase method determination kit, which is used for quantitative analysis of glucose concentration in serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical testing.