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 Becton…

Intended purpose

Reagents, products or consumables, that are intended to be used for system set-up and / or verification processes such as counting methods including dilution and staining process, method set-up and blood enumeration, together with the adjustment of settings for, in vitro diagnostic instruments (such as flow cytometers) within a clinical laboratory.

TGA Public Summary