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Bio-Rad Platelia Dengue IgG Capture - HSA Registration DE0018967

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.

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CLASS C IVD
DE0018967
Bio-Rad Platelia Dengue IgG Capture
HSA Registration Number: DE0018967
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Product Description

Plateliaโ„ข 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.

Device 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 Owner
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