YY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit

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Scope

This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation, and storage of the free prostate specific antigen
quantitative labelling immunoassay kit.
This standard is applicable to the kit which quantitatively determines the free prostate
specific antigen (fPSA) by the principle of double antibody sandwich method (hereinafter
referred to as. fPSA kit). It includes the immunoassay kit of quantitative determination of
fPSA by using labelling methods such as enzyme labelling, (electrical) chemiluminescent
labelling, (time resolution) fluorescence labelling AS the capture antibody; and using
carriers such as microplates, pipes, magnetic particles, microbeads, and plastic beads AS
the coated antibody.
This standard does not apply to.
a) Reagent which is used to qualitatively or semi-quantitatively determine fPSA by
colloidal gold or other methods (such as. test paper strip, etc.);
b) Various types of fPSA 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.
GB/T 191 Packaging - Pictorial marking for handling of goods

Basic Data

Standard ID	YY/T 1249-2014 (YY/T1249-2014)
Description (Translated English)	Free prostate specific antigen 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	9,961
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB/T 191
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 the principles of the quantitative determination of free prostate-specific antigen (fPSA) kit (hereinafter referred to as: fPSA kit) for a double antibody sandwich assay. Including enzyme-labeled, (e) a chemiluminescent label, (ti