Singapore HSA registration DE0017474
Bio-Rad Syphilis Total Ab
Singapore·CLASS D IVD·Bio-Rad France·Registered September 16, 2015Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0017474
- Registration Date
- September 16, 2015
- Change Notification Approval Date
- March 01, 2023
- Retention Due Date
- September 15, 2025
Product description
The Syphilis Total Ab is a semi-quantitative enzyme immunoassay kit for the detection of total antibodies (IgG, IgM and IgA) to Treponema pallidum in human serum or plasma. It’s indicated for the screening of blood donors, and as an aid in the diagnosis of patients where syphilis infection is suspected in conjunction with clinical signs and symptoms.
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)
- Syphilis Total Ab Syphilis Total Ab
- Model Identifier(s)
- 72530 72531
About this record
Access comprehensive regulatory information for Bio-Rad Syphilis Total Ab 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 DE0017474 and owned by Bio-Rad France. The device was registered on September 16, 2015.
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