This standard specifies the terms and definitions, requirements, experimental methods, identification, labels, instructions for use, packaging, transportation and storage of influenza A virus antigen detection kits (immunochromatography). This standard is applicable to diagnostic kits for rapid detection of influenza A virus antigens by qualitatively detecting influenza A viruses in respiratory secretions and their cultures through immunochromatographic principles such as colloidal gold or latex particles. This standard does not apply to kits used for auxiliary diagnosis of influenza A based on the basic principle of enzyme-related immunochromatography.
YY/T 1443-2016 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1443-2016 history
2016YY/T 1443-2016 Influenza A virus antigen detection kit(immunochromatographic assay)