Device Dossier

Cytomegalovirus (Human herpesvirus 5) IVDs

Device Dossier for Cytomegalovirus (Human herpesvirus 5) IVDs (CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs, Class 3, sponsor Hologic (Australia &…

Intended purpose

The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus DNA in human EDTA plasma and whole blood on the fully automated Panther system. The Aptima CMV Quant Assay is intended for use to aid in the diagnosis and to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

TGA Public Summary