Singapore HSA registration DE0016728
Bio-Rad Geenius HIV 1/2 Confirmatory Assay
Singapore·CLASS D IVD·Bio-Rad·Registered January 09, 2015Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDD00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0016728
- Registration Date
- January 09, 2015
- Change Notification Approval Date
- September 11, 2024
- Retention Due Date
- January 08, 2026
Product description
The Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma samples. The Geenius™ HIV 1/2 Confirmatory Assay is intended for use as an additional test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by screening procedures.
Product Owner
- Name
- Bio-Rad
- Short Name
- Bio-Rad
- 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)
- Geenius HIV1/2 Confirmatory Controls Geenius HIV 1/2 Confirmatory Assay
- Model Identifier(s)
- 72329 72460
About this record
Access comprehensive regulatory information for Bio-Rad Geenius HIV 1/2 Confirmatory Assay 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 DE0016728 and owned by Bio-Rad. The device was registered on January 09, 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