ProciseDx Procise FCP Assay - HSA Registration DE0509724
Access comprehensive regulatory information for ProciseDx Procise FCP Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509724 and owned by ProciseDx Inc.. The device was registered on September 03, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Procise FCP assay is a time-resolved fluorescence energy transfer immunoassay for the point of care quantitative determination of Fecal Calprotectin Protein (FCP) levels in human stool using the ProciseDx System. The Procise FCP test is intended for use in clinical laboratory, point-of-care laboratory and physician’s office settings. The product is intended to be used to aid in the assessment of mucosal bowel inflammation. Elevated levels of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn’s disease), and in the differentiation of IBD from irritable bowel syndrome (IBS).