Device Dossier

General laboratory reagent and consumables IVDs

Device Dossier for General laboratory reagent and consumables IVDs (CT946 - General laboratory reagent and consumables IVDs, Class 2, sponsor Thermo…

Intended purpose

For the isolation and purification of viral nucleic acids. The kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of magnetic bead purification, either manual or automated, and in vitro diagnostic procedures.

TGA Public Summary