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Singapore HSA registration DE0015557

Bio-Rad Genie Fast HIV 1/2

Singapore flagSingapore·CLASS D IVD·Bio-Rad France·Registered May 23, 2014
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDD00106
HS Code
38220090
Registration information
Registration Number
DE0015557
Registration Date
May 23, 2014
Change Notification Approval Date
March 01, 2023
Retention Due Date
May 22, 2025
Product description
The fast test device uses the Immunochromatography (ICT or lateral migration) technique to detect anti-HIV-1 and anti-HIV-2 antibodies in human serum, plasma, venous blood and capillary blood. This kit is not intended for blood donor screening. Any sample found to be reproducibly positive must be confirmed using an appropriate method (Western-Blot or equivalent) to prove the presence of anti-HIV antibodies.
Product Owner
Name
Bio-Rad France
Short Name
Bio-Rad France
Address
3, boulevard Raymond Poincare, 92430 Marnes-la-Coquette, FRANCE
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
Genie Fast HIV 1/2
Model Identifier(s)
72330
About this record

Access comprehensive regulatory information for Bio-Rad Genie Fast HIV 1/2 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 DE0015557 and owned by Bio-Rad France. The device was registered on May 23, 2014.

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