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Bio-Rad Syphilis Total Ab - HSA Registration DE0017474

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.

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CLASS D IVD
DE0017474
Bio-Rad Syphilis Total Ab
HSA Registration Number: DE0017474
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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. Itโ€™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.

Device 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 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)
Syphilis Total Ab Syphilis Total Ab
Model Identifier(s)
72530 72531