HSA · registration DE0509521Abbott Diagnostics Medical Determine™ HBsAg 2
SingaporeImmunologyClass DAbbott Diagnostics Medical Co., Ltd.
Official record identity
- Registration number
- DE0509521
- Model name
- Determine™ HBsAg 2; Determine™ HBsAg 2
- Model identifier
- 7D2942; 7D2943
- Registration date
- July 12, 2024
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Abbott Diagnostics Medical Co., Ltd.
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official 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.
Additional source fields
- Product owner address
- 357 Matsuhidai,, Matsudo-shi, Chiba,, 270-2214, Japan
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.