Device Dossier

Multiple clinical chemistry constituent IVDs

Device Dossier for Multiple clinical chemistry constituent IVDs (CT889 - Multiple clinical chemistry constituent IVDs, Class 2, sponsor Revvity). ARTG…

Intended purpose

The assay is intended for the quantitative measurement of the activity of the enzymes acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid α glucosidase (GAA), β galactocerebrosidase (GALC), α-galactosidase A (GLA) and α-L-iduronidase (IDUA) in dried blood spots (DBS).

TGA Public Summary