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 3, sponsor Genetic…

Intended purpose

EasyScreenTM Sample Processing Kits comprise a method to isolate and sodium bisulphite convert microbial nucleic acid from clinical specimens or bacterial cultures. Output from this kit is purified bisulpite converted nucleic acids, which are intended for use with HGS microbial detection IVD devices, which detect various microorganisms. It is an IVD intended to be used in a pathology laboratory or similar by trained personnel.

TGA Public Summary