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 Emergo).…

Intended purpose

The Nucleic Acid Purification Kit is used for extraction and purification of viral nucleic acid from human biological specimens. The purified viral nucleic acid is suitable for clinical in vitro testing or use in amplification-based in vitro diagnostic assays. Diagnostic results obtained using the nucleic acid purified with the kit must be interpreted in conjunction with other clinical or laboratory data. The kit is intended to be used by professional users, such as technicians or physicians who are trained in molecular biological techniques. For professional use only. For in vitro diagnostic use only.

TGA Public Summary