ProciseDx Procise ADL Assay - HSA Registration DE0510466
Access comprehensive regulatory information for ProciseDx Procise ADL 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 DE0510466 and owned by ProciseDx Inc.. The device was registered on March 14, 2025.
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 ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in human capillary whole blood collected by finger prick, venous whole blood, and venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer. Measurement of adalimumab can be used as an aid in the management of inflammatory bowel diseases (IBD): Crohn’s disease and ulcerative colitis, in conjunction with other laboratory findings, procedure findings, and clinical signs and symptoms. The test is intended for use in clinical laboratory and point-of-care laboratory.