Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Aim Discovery Solutions).…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
Intended purpose
The NOVEOS® Specific IgE assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. The NOVEOS Specific IgE is to be used with the NOVEOS Immunoassay Analyzer and the NOVEOS flex Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.