YY/T 1160-2009: Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)

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Scope

This Standard specifies the terms and definitions, classification, requirements, test methods,
inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of
carcinoembryonic antigen (CEA) quantitative determination reagent (kit) (chemiluminescent
immunoassay).
This Standard applies to the quantitative determination of human carcinoembryonic antigen (CEA)
quantitative detection reagent (kit) (hereinafter referred to as "CEA reagent (kit)") based on the
principle of chemiluminescent immunoassay. It includes enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (box) with carriers such as microplates, pipes,
magnetic particles, microbeads, and plastic beads.
The Standard is not applicable to the requirements to the calibration products and quality control
products in the kit.

Basic Data

Standard ID	YY/T 1160-2009 (YY/T1160-2009)
Description (Translated English)	Carcinoembryonic Antigen 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	10,150
Date of Issue	2009-12-30
Date of Implementation	2011-06-01
Quoted Standard	GB/T 21415-2008
Regulation (derived from)	China Food and Drug Administration Announcement 2009 No.83
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the carcinoembryonic antigen (CEA) quantitative assay (box) (chemiluminescent immunoassay) the terms and definitions, classification, requirements, test methods, inspection rules, marking, labeling, instructions, packaging, transport and storage and so on. This standard applies to chemiluminescence immunoassay for the quantitative determination of the principle of carcinoembryonic antigen (CEA) quantitative assay (box) (hereinafter referred to as "CEA Reagent (Box) ", including microplates, tubes, magnetic particles, micro- beads and plastic beads as the carrier of enzymatic and non- enzymatic chemiluminescence immunoassay reagent (box) this standard does not apply to the kit calibrators and control materials requirements.