Device Dossier

JC virus IVDs

Device Dossier for JC virus IVDs (CT757 - JC virus IVDs, Class 3, sponsor Elitechgroup). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

The product JCV ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids Real-Time PCR assay for the detection and quantification of the DNA of Human Polyomavirus JC (JCV) extracted from clinical specimens.

TGA Public Summary