YY/T 1197-2013: Alanine aminotransferase diagnostic kit (IFCC method)

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Scope

This standard specifies the determination principle, requirements, test method, signs, instructions,
packaging, transport and storage, etc. of alanine aminotransferase diagnostic kit (IFCC method).
This standard applies to the quality control of alanine aminotransferase diagnostic kit (IFCC method).
This product is used for in-vitro quantitative determination of the alanine aminotransferase activity in
human serum or plasma.

Basic Data

Standard ID	YY/T 1197-2013 (YY/T1197-2013)
Description (Translated English)	Alanine aminotransferase diagnostic kit (IFCC method)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	10,120
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 measurement principle enzyme alanine aminotransferase assay kit (IFCC method), requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to alanine aminotransfer