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 Australia…

Intended purpose

For isolation and purification of high-quality viral DNA / RNA from serum, plasma, swab preservation solution or various virus preservation solutions. Only available for lab on IVD application. During the nucleic acid extraction process, the magnetic bead adsorption principle is used to adsorb, transfer, and purify nucleic acids through special magnetic beads to automatically complete the nucleic acid extraction.

TGA Public Summary