YY/T 1213-2013: Follicle stimulating hormone quantitative labelling immunoassay kit

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Scope

This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation and storage etc. of the follicle stimulating hormone
quantitative labelling immunoassay kit.
This standard is applicable to follicle stimulating hormone (FSH) kit [herein after referred
to as “FSH kit”] that is quantitatively determined and based on the principle of double
antibody sandwich method. It includes the FSH immunoassay kit of quantitative
determination by using enzyme labelling, (electrical) chemiluminescent labelling, (time
resolution) fluorescence labelling and other labelling methods as the capture antibodies;
and taking micro-plates, tubes, magnetic particles, micro-beads and plastic beads and
others as the carrier coated antibodies.
This standard does not apply to.
a) Colloidal gold labeled FSH test strip;
b) Various types of FSH radio-immunity or IRMA kit labeled with 125I and other
radioactive isotopes.

Basic Data

Standard ID	YY/T 1213-2013 (YY/T1213-2013)
Description (Translated English)	Follicle stimulating hormone 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	9,993
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: FSH quantitative labeled immunoassay kit classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to: Principle quantitative determination of follicl