YY/T 1184-2010 English PDF

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YY/T 1184-2010: Monoclonal antibody reagent tor flow cytometer
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1184-2010	229	Add to Cart	3 days	Monoclonal antibody reagent tor flow cytometer	Valid

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Basic data

Standard ID: YY/T 1184-2010 (YY/T1184-2010)
Description (Translated English): Monoclonal antibody reagent tor flow cytometer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 10,178
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 191; YY/T 0466.1-2009
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the flow cytometry using monoclonal antibody reagents General technical requirements for quality inspection. Including terminology and definitions, classification and naming requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to medical laboratories using clinical samples by flow cytometry analysis of lymphocyte phenotype, leukemia/lymphoma sub-type or other disease diagnosis and monitoring of the use of flow cytometry using monoclonal antibody reagents (less referred reagents), direct fluorescent antibody immune markers (also known as direct standard Hangzhou body), can be used for intracytoplasmic membrane antigens and antigen detection. Agent may be a direct standard fluorescein-labeled antibody may be two or more direct standard antibody mixture.

YY/T 1184-2010: Monoclonal antibody reagent tor flow cytometer

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Monoclonal antibody reagent tor flow cytometer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Flow cytometry using monoclonal antibody reagents Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard is evaluated by flow cytometry using monoclonal antibody reagent quality basis. 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 by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed. 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. Beijing Medical Device Testing, Beckman Coulter Trading (China) Co., Becton Dickinson Medical Devices (on Sea) Limited. The main drafters of this standard. Bi Chunlei, Xue Xiangjun, Wu Xu, Du Haiou, Yangzong Bing, He Xueying. Flow cytometry using monoclonal antibody reagents

1 Scope

This standard specifies the flow cytometry using monoclonal antibody reagents general technical requirements for quality inspection. Including the terms and definitions, classifications and Name, requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to medical laboratories for clinical samples using flow cytometry lymphocyte phenotyping, leukemia/lymphoma classification Or flow cytometric diagnosis and monitoring of other diseases that are used with the monoclonal antibody reagents (hereinafter referred to as agent) for direct immunolabeling Fluorescent antibody (also known as a straight-labeled antibody) can be used for membrane antigens and cytoplasmic antigen detection. Reagents can be a straight-FITC-labeled antibody, or may be two or more straight-labeled antibody mixture.

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 0466.1-2009 medical equipment used with medical device labels, labeling and information. General Claim

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Antibody antibody The immunogenic substance stimulating B- lymphocytes, and are able to bind specific immune globulin. NOTE. immune molecules immunogenic material comprising one or more portions with a unique chemical composition that epitope. [YY/T 0639-2008, the definition 3.9] 3.1.1 Polyclonal antibodies polyclonalantibody It can react with the substance class of immunogenic antibodies specifically reactive mixture. [YY/T 0639-2008, the definition 3.9.1] 3.1.2 Monoclonal antibodies monoclonalantibody Antibodies specifically reactive with a single epitope can occur in some of the immunogenic agent. [YY/T 0639-2008, the definition 3.9.2] 3.2 Positive cells positivecel Cells with reagents specific antigen. 3.3 Negative cells negativecel It does not express a specific antigen reagent of cells. ......

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