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Bio-Rad TPHA - HSA Registration DE0017761

Access comprehensive regulatory information for Bio-Rad TPHA in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0017761 and owned by Bio-Rad France. The device was registered on January 07, 2016.

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 D IVD
DE0017761
Bio-Rad TPHA
HSA Registration Number: DE0017761
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Product Description

TPHA kits are intended for use for the qualitative and semiquantitative detection of antibodies to Treponema pallidum in human serum and plasma. The product may be used for the screening of blood donors, and to aid in the diagnosis of patients where syphilis infection is suspected.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0017761
Registration Date
January 07, 2016
Change Notification Approval Date
February 19, 2025
Retention Due Date
January 06, 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)
TPHA TPHA
Model Identifier(s)
72503 72504