Device Category Dossier

CT749 - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Device Category Dossier for CT749 - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs. Australian ARTG records, sponsors, device class — compiled…

Herpes simplex virus in vitro diagnostic devices employ nucleic acid Real-Time PCR assays or immunoassays to detect and quantify viral DNA or antibodies (IgG class) to HSV-1 and HSV-2 in clinical specimens including serum and plasma. These devices are used to assess immune status, aid in diagnosing HSV infection, and support differential diagnosis of conditions presenting with similar symptoms.