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Bio-Rad RPR - HSA Registration DE0018672

Access comprehensive regulatory information for Bio-Rad RPR 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 DE0018672 and owned by Bio-Rad. The device was registered on October 18, 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 C IVD
DE0018672
Bio-Rad RPR
HSA Registration Number: DE0018672
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Product Description

RPR kits are intended for use for the qualitative and semiquantitative detection of non treponemal syphilis-associated antibodies (reagin) in human serum and plasma as an aid in the diagnosis in syphilis infection.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0018672
Registration Date
October 18, 2016
Change Notification Approval Date
February 19, 2025
Retention Due Date
October 17, 2025
Product Owner
Short Name
Bio-Rad
Address
3, bvd 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)
RPR RPR
Model Identifier(s)
72515 72516