This document specifies the quality evaluation requirements, test methods, labels and instructions, packaging, transportation and storage of the new coronavirus IgM antibody detection kit. This document is applicable to kits for in vitro qualitative detection of novel coronavirus-specific IgM antibodies in human serum, plasma and whole blood using the principles of immunochromatography, enzyme-linked immunoassay and chemiluminescence.
GB/T 40984-2021 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
GB/T 40984-2021 history
2021GB/T 40984-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgM antibody detection kit