Singapore HSA registration DE0018967
Bio-Rad Platelia Dengue IgG Capture
Singapore·CLASS C IVD·Bio-Rad France·Registered February 14, 2017Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0018967
- Registration Date
- February 14, 2017
- Change Notification Approval Date
- March 04, 2021
- Retention Due Date
- February 13, 2026
Product description
Platelia™ Dengue IgG Capture assay is a microplate immunoassay based on immuno-capture format for qualitative detection of elevated Dengue virus specific IgG in human serum or plasma. The test is intended as an aid in diagnosis of patients with clinical symptoms consistent with secondary dengue infection.
Product Owner
- Name
- Bio-Rad France
- Short Name
- Bio-Rad France
- Address
- 3, boulevard Raymond Poincare, 92430 Marnes-la-Coquette, FRANCE
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- Platelia Dengue IgG Capture
- Model Identifier(s)
- 72832
About this record
Access comprehensive regulatory information for Bio-Rad Platelia Dengue IgG Capture in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0018967 and owned by Bio-Rad France. The device was registered on February 14, 2017.
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 C IVD