Singapore HSA registration DE0510465
ProciseDx Procise IFX Assay
Singapore·CLASS B IVD·ProciseDx Inc.·Registered March 14, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0510465
- Registration Date
- March 14, 2025
- Retention Due Date
- March 13, 2026
Product description
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab (IFX) levels in human capillary whole blood collected by finger prick, venous whole blood, and venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurement of infliximab 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.
Product Owner
- Name
- ProciseDx Inc.
- Short Name
- ProciseDx Inc.
- Address
- 9449 Carroll Park DR, San Diego, CA, 92121 USA, UNITED STATES
Registrant
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
- Model Name(s)
- Procise IFX Assay
- Model Identifier(s)
- 4828
About this record
Access comprehensive regulatory information for ProciseDx Procise IFX 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 DE0510465 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD