YY/T 1443-2016 English PDF

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YY/T 1443-2016: Influenza A virus antigen detection kit(immunochromatographic assay)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1443-2016	159	Add to Cart	3 days	Influenza A virus antigen detection kit(immunochromatographic assay)	Valid

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Basic data

Standard ID: YY/T 1443-2016 (YY/T1443-2016)
Description (Translated English): Influenza A virus antigen detection kit(immunochromatographic assay)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,898
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration

YY/T 1443-2016: Influenza A virus antigen detection kit(immunochromatographic assay)

---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.
Influenza A virus antigen detection kit (immunochromatographic assay) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Influenza A virus antigen detection kit 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. China Food and Drug Administration Research Institute, Guangzhou Wanfu Biotechnology Co., Ltd. The main drafters of this standard. Shen Shu, Shi Dawei, Zhang Chuntao, Li Meilan. Influenza A virus antigen detection kit

1 Scope

This standard specifies the terminology and definition, requirements, experimental methods, labeling, labeling of influenza A virus antigen detection kit (immunochromatography) Sign, instructions, packaging, shipping and storage. This standard applies to colloidal gold or latex particles such as immunochromatography principle, qualitative detection of respiratory secretions and their culture Influenza A virus to quickly detect influenza A virus antigen diagnostic kit. This standard does not apply to the enzyme-related immunochromatography as the basic principles for the diagnosis of influenza A kit.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Influenza A virus antigen detection kit (immunochromatography) influenzaAvirusantigendetectionkit (immuno- chromatographicassay Application of the principle of immunochromatography, detection of human respiratory secretions and their culture in the influenza virus antigen kit.

4 requirements

4.1 Physical properties 4.1.1 appearance a) The packaging should be clean and tidy. Detection of reagents should be no damage, complete, no burr, material attached firmly. b) kit components should be complete, should include pre-treatment of influenza virus liquid components and test strips (cards) and so on. 4.1.2 Film width Film width should not be less than 2.5mm. 4.1.3 Liquid migration speed Liquid migration speed should not be less than 10mm/min. ......

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