This standard specifies the technical requirements, test methods, identification, labels and instructions, packaging, transportation and storage of herpes simplex virus IgM antibody detection reagents (kits) [hereinafter referred to as "reagents (kits)"]. This standard is suitable for the qualitative detection of herpes simplex virus type 1+2 IgM antibody detection reagents (boxes) in human serum/plasma. The methodologies include enzyme-linked immunoassay, chemiluminescence method, immunofluorescence method, western blotting method, etc.
YY/T 1483-2016 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