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 Werfen).…

Intended purpose

IVDs that are general laboratory reagents, products or consumables, that are intended to be used specifically as an IVD in the testing of specimens within a clinical laboratory.

TGA Public Summary