Device Dossier

Elecsys HIV combi PT (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys HIV combi PT (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay (HIV1/HIV2…

Intended purpose

Immunoassay for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1, including group O, and HIV-2 in human serum and plasma using the Elecsys and cobas e analytical systems

Functional description

Immunoassay for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1, including group O, and HIV-2 in human serum and plasma using the Elecsys and cobas e analytical systems

TGA Public Summary