YY/T 1240-2014: D-Dimer reagent (kit)

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Scope

This Standard specifies the term and definition, requirements, test methods, symbols,
labels and instructions, packing, transportation, and storage of D-Dimer quantitative
detection reagent (kit).
This Standard applies to immunoturbidimetric D-Dimer reagent (kit) (hereinafter referred
to as D-D reagent) used in laboratory.

Basic Data

Standard ID	YY/T 1240-2014 (YY/T1240-2014)
Description (Translated English)	D-Dimer reagent (kit)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	12,163
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB/T 191; GB 3100; GB 3101; GB 3102.1; GB 3102.2; GB 3102.3; GB 3102.4; GB 3102.5; GB 3102.6; GB 3102.7; GB 3102.8; GB 3102.9; GB 3102.10; GB 3102.11; GB 3102.12; GB 3102.13; YY/T 0466.1
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to laboratory with immune nephelometry D- dimer quantitative detection reagent (box) products. This Standard specifies the D- dimer quantitative detection reagent (box) of terminology, definitions, requirements, test methods, marking