Device Dossier

Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Device Dossier for Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs (CT749 - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs, Class 3,…

Intended purpose

Immunoassays for the in vitro qualitative determination of IgG class antibodies to HSV-1 and HSV-2 in human serum and plasma. The test are intended for use as an aid in the assessment of immune status and as aid in the diagnosis of HSV infection

TGA Public Summary