Singapore HSA registration DE0504244
Bio-Rad Geenius HCV Supplemental Assay
Singapore·CLASS D IVD·Bio-Rad·Registered March 18, 2020Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504244
- Registration Date
- March 18, 2020
- Change Notification Approval Date
- September 11, 2024
- Retention Due Date
- March 17, 2026
Product description
The Geenius™ HCV Supplemental Assay is a qualitative single-use immunochromatographic assay for the confirmation of the presence of antibodies associated with infection caused by the Hepatitis C Virus (HCV) in human venous whole blood, serum, or plasma specimens from individuals (including blood donors) or patients. It is intended for use as an aid in the diagnosis of hepatitis C infection, to confirm the presence of anti-HCV antibodies in specimens found to be reactive by screening procedures. The reading and interpretation process is to be performed only through automated reading using the Geenius™ Reader and Software.
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 HCV Supplemental Assay Geenius HCV Supplemental Control
- Model Identifier(s)
- 92501 92502
About this record
Access comprehensive regulatory information for Bio-Rad Geenius HCV Supplemental 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 DE0504244 and owned by Bio-Rad. The device was registered on March 18, 2020.
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