YY/T 1218-2013: Thyroid-stimulating hormone quantitative labelling immunoassay kit

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Scope

This Standard specifies the classification, requirements, test methods, marks, labels,
instructions, packaging, transportation, and storage of the thyroid-stimulating hormone
quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative determination of thyroid-stimulating
hormone (TSH) kit (hereinafter referred to as “TSH kit”) based on the principle of double
antibody sandwich method. It includes the immunoassay kit for quantitative determination
of TSH by using labelling methods such as enzyme labelling, (electrical)
chemiluminescent labelling, and (time resolution) fluorescence labelling AS capture
antibody; and taking microplates, pipes, magnetic particles, microbeads and plastic beads
etc. AS the carrier coated antibody.
This Standard does not apply to.
a) Colloidal gold labelled TSH test strip;
b) Various types of radio-immunity or IRMA kit labelled with 125I and other radioactive
isotopes.
2  Normative references
The articles contained in the following documents have become part of this Document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
YY/T 0466.1-2009 Medical devices -- Symbols to be used with medical device labels,
labelling and information to be supplied -- Part 1. General requirements

Basic Data

Standard ID	YY/T 1218-2013 (YY/T1218-2013)
Description (Translated English)	Thyroid-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	9,955
Quoted Standard	YY/T 0466.1
Regulation (derived from)	State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the thyrotropin labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the principle of the quan