YY/T 1233-2014: Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)

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Scope

This Standard specifies the terms and definitions, requirements, test methods,
marking, labeling, instructions, packaging, transportation, and storage of cardiac
troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent
immunoassay).
This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI)
quantitative detection reagent (kit) [hereinafter referred to as "cTnI reagent (kit)"] by
the principal of chemiluminescent immunoassay, including the enzymatic and
non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers
such as microplates, tubes, and magnetic particles.
This Standard does not apply to the requirements for the calibrator and control
materials in reagent (kit).

Basic Data

Standard ID	YY/T 1233-2014 (YY/T1233-2014)
Description (Translated English)	Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	8,838
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB/T 21415
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 human cardiac troponin -I (cTnI) reagent (box) quantitative determination principle to CLIA law, including microplates, tubes, magnetic particles as carrier enzymatic and non-enzymatic chemiluminescence immunoassay assay reagent (