This standard specifies the requirements, test methods, identification, labels and instructions, packaging, transportation and storage of cytomegalovirus IgG/IgM antibody detection reagents (kits) [hereinafter referred to as "reagents (kits)"]. This standard is suitable for the qualitative detection of cytomegalovirus IgG/IgM antibody detection reagent (box) (enzyme-linked immunoassay), cytomegalovirus IgG/IgM antibody detection reagent (box) (chemiluminescence method), cytomegalovirus IgG/IgM antibody detection reagent (box) (chemiluminescence method), cytomegalovirus in human serum/plasma Virus IgG/IgM antibody detection reagent (box) (immunofluorescence method), cytomegalovirus IgG/IgM antibody detection reagent (box) (immunoblotting method), etc.