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…
- GMDN category: CT889 - Multiple clinical chemistry constituent IVDs
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).