Singapore HSA registration DE0509521
Abbott Diagnostics Medical Determine™ HBsAg 2
Singapore·CLASS D IVD·Abbott Diagnostics Medical Co., Ltd.·Registered July 12, 2024Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509521
- Registration Date
- July 12, 2024
- Retention Due Date
- July 11, 2025
Product description
Determine™ HBsAg 2 is an in vitro, visually read, qualitative immunoassay for the detection of Hepatitis B Surface Antigen (HBsAg) in human capillary and venous whole blood, plasma or serum. The test is intended as an aid in the diagnosis of HBV infection through detection of HBsAg from infected individuals. The test is not intended for screening blood donors. The test is for professional use only.
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
Model information
- Model Name(s)
- Determine™ HBsAg 2 Determine™ HBsAg 2
- Model Identifier(s)
- 7D2942 7D2943
About this record
Access comprehensive regulatory information for Abbott Diagnostics Medical Determine™ HBsAg 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 DE0509521 and owned by Abbott Diagnostics Medical Co., Ltd.. The device was registered on July 12, 2024.
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