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 iDigoxin, iPhenobarbital, and iPhenytoin assays are in vitro chemiluminescent microparticle immunoassays (CMIA) for the quantitative measurement of digoxin, phenobarbital, and phenytoin in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin and phenobarbital overdose, and in monitoring serum levels of digoxin, phenobarbital, and phenytoin to help ensure appropriate therapeutic management.