Device Category Dossier

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Device Category Dossier for HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay. Australian ARTG records, sponsors, device class — compiled…

HIV antigen/antibody combo assays are paramagnetic particle chemiluminescent immunoassays that simultaneously detect and differentiate HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma. These assays are used as an aid in the diagnosis of HIV-1 and HIV-2 infection in individuals of all ages, as screening tests for blood and plasma donors, and to screen donors whose cells, tissues and organs are intended for transplant.