Singapore HSA registration DE0019264
Bio-Rad Platelia Dengue IgA Capture
Singapore·CLASS C IVD·Bio-Rad France·Registered May 24, 2017Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0019264
- Registration Date
- May 24, 2017
- Change Notification Approval Date
- March 04, 2021
- Retention Due Date
- May 23, 2025
Product description
Platelia™ Dengue IgA Capture assay is a microplate immunoassay based on immuno-capture format for qualitative detection of Dengue virus specific IgA in human serum or plasma. The test is intended as an aid in diagnosis of patients with clinical symptoms consistent with dengue acute infection. Platelia™ Dengue IgA Capture should be used in conjunction with other serology assays for dengue diagnosis.
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 IgA Capture
- Model Identifier(s)
- 72831
About this record
Access comprehensive regulatory information for Bio-Rad Platelia Dengue IgA 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 DE0019264 and owned by Bio-Rad France. The device was registered on May 24, 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.
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