This standard specifies the terms and definitions, requirements, test methods, labels and instructions, as well as packaging, transportation and storage of influenza A virus nucleic acid detection kits (fluorescence PCR method) (hereinafter referred to as "kits"). This standard applies to kits based on the principle of fluorescence PCR for the qualitative detection of influenza A virus nucleic acid in human nose, throat swabs or other respiratory secretion samples. This standard does not apply to kits based on the principle of isothermal amplification for the qualitative detection of influenza A virus nucleic acid in human nose, throat swabs or other respiratory secretion samples.
YY/T 1596-2017 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 29791.2 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use
YY/T 1596-2017 history
2017YY/T 1596-2017 Influenza A virus nucleic acid detection kit(fluorescent PCR)