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Bio-Rad VRESelect - HSA Registration DE0017288

Access comprehensive regulatory information for Bio-Rad VRESelect 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 DE0017288 and owned by Bio-Rad France. The device was registered on July 01, 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 C IVD
DE0017288
Bio-Rad VRESelect
HSA Registration Number: DE0017288
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Product Description

VRESelect is a selective and differential chromogenic medium for the qualitative detection and identification of vancomycinresistant Enterococcus faecium (VRE-fm) and vancomycin-resistant Enterococcus faecalis (VRE-fs). The test is performed on rectal swabs or fecal specimens to screen patients or healthcare workers for VRE gastrointestinal colonization.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0017288
Registration Date
July 01, 2015
Change Notification Approval Date
January 25, 2024
Retention Due Date
June 30, 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)
VRESelect VRESelect
Model Identifier(s)
63751 63752