Singapore HSA registration DE0017761
Bio-Rad TPHA
Singapore·CLASS D IVD·Bio-Rad France·Registered January 07, 2016Device 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 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.
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)
- TPHA TPHA
- Model Identifier(s)
- 72503 72504
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD