Abbott Diagnostics Medical Determine™ HBsAg 2 - HSA Registration DE0509521
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.
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.