Singapore HSA registration DE0509724
ProciseDx Procise FCP Assay
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509724
- Registration Date
- September 03, 2024
- Retention Due Date
- September 02, 2025
Product description
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).
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 FCP Assay Procise Stool Collection Kit Procise Stool Collection Kit
- Model Identifier(s)
- 4664 4912 4913
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD