Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Grifols). ARTG record,…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
- Sponsor: Grifols
Intended purpose
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Anti-Drug Antibodies in human serum samples. The amount of Anti-Drug Antibodies, when considered in conjunction with drug levels and clinical findings, like disease activity, can contribute valuable information to the physician to assess the efficacy of therapies with drug.