Device Dossier
Clinical chemistry therapeutic drug monitoring IVDs
Device Dossier for Clinical chemistry therapeutic drug monitoring IVDs (CT860 - Clinical chemistry therapeutic drug monitoring IVDs, Class 3, sponsor…
- GMDN category: CT860 - Clinical chemistry therapeutic drug monitoring IVDs
Intended purpose
The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.