Singapore HSA registration DE0502692
Bio-Rad Access HCV Ab V3
Singapore·CLASS D IVD·Bio-Rad·Registered January 18, 2019Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0502692
- Registration Date
- January 18, 2019
- Change Notification Approval Date
- March 03, 2025
- Retention Due Date
- January 17, 2026
Product description
The Access HCV Ab V3 is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of antibodies to the hepatitis C virus in human serum or plasma (Lithium heparin, K2-EDTA, K3-EDTA, citrate, CPDA-1 or ACD), using the Access Immunoassay Systems. The Access HCV Ab V3 is intended to be used as an aid in the diagnosis of HCV infection and as a screening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens.
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
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
- Model Name(s)
- Access HCV Ab V3 Access HCV Ab V3 Calibrators Access HCV Ab V3 QC
- Model Identifier(s)
- B33458 B33459 B33460
About this record
Access comprehensive regulatory information for Bio-Rad Access HCV Ab V3 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 DE0502692 and owned by Bio-Rad. The device was registered on January 18, 2019.
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