YY/T 1214-2013: Human chorionic gonadotrophin quantitative labelling immunoassay kit

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Scope

This Standard specifies the classification, requirements, test method, marks, labels,
operating instructions, packaging, transportation, and storage of the human chorionic
gonadotrophin quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative detection of human chorionic gonadotrophin
(HCG) quantitative labelling immunoassay kit [herein after referred to as “HCG reagent
(kit)”] that is based on the principle of double antibody sandwich method. It includes the
HCG immunoassay kit for quantitative detection by using labelling methods such as
enzyme labelling, (electrical) chemiluminescent labelling, (time resolution) fluorescence
AS capture antibody; and using microplates, pipes, magnetic particles, microbeads and
plastic beads and others AS the carrier coated antibody.
The Standard does not apply to.
a) Colloidal gold labelled HCG test strip;
b) Various types of HCG radio-immunity or IRMA reagent kit labelled with 125I and other
radioactive isotopes.

Basic Data

Standard ID	YY/T 1214-2013 (YY/T1214-2013)
Description (Translated English)	Human chorionic gonadotrophin quantitative labelling immunoassay kit
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	9,981
Quoted Standard	YY/T 0466.1
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: a quantitative marker of human chorionic gonadotropin immunoassay kit classification, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: the pri