Device Dossier
BK virus IVDs
Device Dossier for BK virus IVDs (CT758 - BK virus IVDs, Class 3, sponsor Vela Diagnostics). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT758 - BK virus IVDs
Intended purpose
The Sentosa SA BKV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of BK virus (BKV) DNA using Sentosa SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum and urine samples, Sentosa SX Virus Total Nucleic Acid Kit v2.0 is used for DNA extraction; and for human EDTA whole blood samples, Sentosa® SX Whole Blood Kit is used for DNA extraction.