YY/T 1443-2016
Active
Industry standards-Medicine
YY/T 1443-2016 Influenza A virus antigen detection kit(immunochromatographic assay)
YY/T 1443-2016 Influenza A virus antigen detection kit(immunochromatographic assay)
Basic Information
Standard Code:
YY/T 1443-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
8 pages
Scope
This standard specifies the terms and definitions, requirements, experimental methods, marking, labeling, user manuals, packaging, transportation, and storage of influenza A virus antigen detection kits (immunochromatography).
This standard applies to diagnostic kits that use immunochromatography principles such as colloidal gold or latex particles to qualitatively detect influenza A virus in respiratory secretions and their cultures, in order to quickly detect the influenza A virus antigen.
This standard does not apply to kits that use enzyme-related immunochromatography as the basic principle for assisting in the diagnosis of influenza A.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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