This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of Helicobacter pylori antibody detection kits (colloidal gold method). This standard applies to the quality control of kits for the qualitative detection of Helicobacter pylori antibodies in human serum or plasma (hereinafter referred to as: Helicobacter pylori antibody detection kits) based on the colloidal gold method.
YY/T 1423-2016 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 1423-2016 history
2016YY/T 1423-2016 Testing kit for helicobacter pylori antibody(colloidal gold)