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YY/T 1524-2017 English PDF (YY/T1524-2017)

YY/T 1524-2017 English PDF (YY/T1524-2017)

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YY/T 1524-2017: a-L-Fucosidase (AFU) Assay Kit (CNPF Substrate Method)

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Scope

This Standard specifies the requirements, test methods, label and use instructions,
package, transportation and storage of α-L-fucosidase (AFU) assay kit.
This Standard is applicable to reagent (kit) (hereinafter referred to as kit) performing
quantitative detection by CNPF (2-chloro-4-nitrophenyl-α-L-fucoylpyranoside)
substrate method against the α-L-fucosidase in human serum or plasma; including the
reagents used on the manual and semi-automatic, fully automated biochemical
analyzers.

Basic Data

Standard ID YY/T 1524-2017 (YY/T1524-2017)
Description (Translated English) a-L-Fucosidase (AFU) Assay Kit (CNPF Substrate Method)
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,840
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Regulation (derived from) China Food and Drug Administration Announcement 2017 No. 38
Issuing agency(ies) State Food and Drug Administration


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