Powered by Google-Search & Google-Books Chinese Standards Shop Database: 169760 (Nov 28, 2020)
HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 1252-2015

Chinese Standard: 'YY/T 1252-2015'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1252-2015English169 Add to Cart Days<=3 Total IgE guantitative labelling immunoassay kit Valid YY/T 1252-2015
YY/T 1252-2015Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY/T 1252-2015 (YY/T1252-2015)
Description (Translated English) Total IgE guantitative labelling immunoassay kit
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,818
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard GB/T 191; YY/T 0466.1
Drafting Organization Chinese Institute of Food and Drug test
Administrative Organization National medical clinical testing laboratory and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard specifies the total IgE labeled immunosorbent assay kit for the quantitative quality requirements, test methods, instructions for use, marking, labeling and packaging, transportation and storage. This Standard applies to conduct quantitative determination of total IgE labeled immunoassay kit. Include enzyme labels, chemiluminescent labels, etc. as the capture antibody labeling method, in microplates, tubes, magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative determination of total IgE assay kit for immunoassay. This Standard does not apply to: a) colloidal gold-labeled total IgE test strip; b) radiolabelled with 125I and other types of RIA or IRMA kit.

YY/T 1252-2015
Total IgE guantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Total IgE quantitative labeled immunosorbent assay kit
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Sun Nan, Liu Yan, Yu Ting, Wang Yumei, noble first.
Total IgE quantitative labeled immunosorbent assay kit
1 Scope
This standard specifies the total IgE labeled immunosorbent assay kit for quantitative quality requirements, test methods, instructions for use, marking, labeling and package
Equipment, transportation and storage.
This standard applies to the quantitative determination of total IgE were labeled immunoassay kit (hereinafter referred to as the kit). Include enzyme labels, of
Chemiluminescent label and the like methods for the capture antibody to microtiter plates, tubes, magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative measurement
Total IgE immunoassay assay kit.
This standard does not apply to.
a) colloidal gold-labeled total IgE test strip;
b) radiolabeled with 125I and other types of RIA or IRMA kit.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
Category 3
The kit can be divided according to different labeling methods ELISA, chemiluminescence, immunofluorescence and other kit, according to the solid support
Different type can be divided into microplates, tubes, magnetic particles, beads and plastic beads as the carrier of the kit; based on the operation can be divided into hand
Duplex operation method and apparatus for automatic operation method of the kit.
4 Requirements
4.1 Appearance
Manufacturers should be based on the characteristics of the packaging of their products provide adequate appearance requirements. Usually the kit components should be composed of characters; inside and outside
Packaging, labeling and other requirements clear.
4.2 blank Limit
Blank limit should not exceed 5.0IU/mL.
4.3 Linear
Within a given manufacturer's range of linear correlation coefficient (r) shall not be less than 0.9900.
Note. The lower limit of the linear range of not more than 5IU/mL, the upper limit of the linear range of not less than 1000IU/mL.
4.4 Accuracy
Accuracy should meet one of the requirements are as follows.
Related standard:   YY/T 1253-2015  YY/T 1254-2015
Related PDF sample:   YY/T 1244-2014  YY/T 1247-2014
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2020