Device Dossier
BK virus IVDs
Device Dossier for BK virus IVDs (CT758 - BK virus IVDs, Class 3, sponsor Elitechgroup). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT758 - BK virus IVDs
Intended purpose
The product BKV 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 BK (BKV) extracted from clinical specimens.