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Procise IFX
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.
Details
Device typeTNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay: A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic drug monitoring of a tumour necrosis factor-alpha (TNF-alpha) inhibitor (e.g., infliximab, adalimumab, golimumab and etanercept) in a clinical specimen, using a fluorescent immunoassay method. The assay is typically used to monitor blood levels of anti-TNF-alpha therapeutics in the treatment of autoimmune conditions such as Crohn's disease, ulcerative colitis and rheumatoid arthritis.
FDA categoryInfliximab Test System
Device ID08100322953854
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information