Singapore HSA registration DE0506958
Abbott Diagnostics Medical Determine™ HIV-1/2
Singapore·CLASS D IVD·Abbott Diagnostics Medical Co., Ltd.·Registered June 15, 2022Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506958
- Registration Date
- June 15, 2022
- Retention Due Date
- June 14, 2025
Product description
The Determine™ HIV-1/2 is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood. The test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals. A reactive/positive HIV test result must be followed by confirmatory testing before a final diagnosis of HIV infection can be made.
Product Owner
- Short Name
- Abbott Diagnostics Medical Co., Ltd.
- Address
- 357 Matsuhidai, Matsudo-shi,, Chiba 270-2214,, JAPAN
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- Determine™ HIV-1/2 Determine™ HIV-1/2
- Model Identifier(s)
- 7D2342 7D2343
About this record
Access comprehensive regulatory information for Abbott Diagnostics Medical Determine™ 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 DE0506958 and owned by Abbott Diagnostics Medical Co., Ltd.. The device was registered on June 15, 2022.
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