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 Equinox…

Intended purpose

The 3DMed extraction and purification kits are designed for the rapid extraction and purification of nucleic acids from clinical specimens using magnetic bead-based technology. Purified nucleic acids can be directly used for downstream applications such as RT-qPCR. The kits are optimized for automated nucleic acid extraction and purification with the ANDiS Automated Nucleic Acids Extraction Systems.

TGA Public Summary