Singapore HSA registration DE0506959
Abbott Diagnostics Medical Determine™ HIV Early Detect
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
- DE0506959
- Registration Date
- June 15, 2022
- Change Notification Approval Date
- April 04, 2025
- Retention Due Date
- June 14, 2025
Product description
Determine™ HIV Early Detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (Ab) to HIV-1 and HIV-2 and the detection of non-immunocomplexed(free) HIV-1 p24 antigen (Ag) in human capillary and venous whole blood, plasma or serum. The test is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in individuals with suspected infection. Reactivity on 1) the Ab bar alone 2) the Ag bar alone or 3) both, the Ab and Ag bars simultaneously, is considered a reactive result suggestive of infection with HIV. The test is for professional use only. 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
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- EDTA Capiliary Tubes Lifetouch Blood Lancets Determine™ Chase Buffer Determine™ HIV Controls Determine™ HIV Early Detect Determine™ HIV Early Detect Determine™ HIV Early Detect SET
- Model Identifier(s)
- 7D2222 7D2233 7D2243 7D2253 7D2842 7D2843 7D2843SET
About this record
Access comprehensive regulatory information for Abbott Diagnostics Medical Determine™ HIV Early Detect 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 DE0506959 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