Device Category Dossier

CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs

Device Category Dossier for CT748 - Cytomegalovirus (Human herpesvirus 5) IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Cytomegalovirus in vitro diagnostic devices are nucleic acid reverse transcription and Real-Time PCR assays that detect and quantify human Cytomegalovirus virion mRNA extracted from non-cellular clinical specimens. These devices are used to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients.