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YY/T 1443-2016: Influenza A virus antigen detection kit(immunochromatographic assay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1443-2016	English	159	Add to Cart	3 days [Need to translate]	Influenza A virus antigen detection kit(immunochromatographic assay)

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

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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. ...