Abbott Diagnostics Korea Bioline™ HCV - HSA Registration DE0510686
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ HCV 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 DE0510686 and owned by Abbott Diagnostics Korea Inc.. The device was registered on May 06, 2025.
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.
The Bioline™ HCV test is an in vitro immunochromatographic, rapid assay designed for the qualitative detection of antibodies specific to HCV, in human serum, plasma, venous whole blood or finger prick whole blood. The Bioline™ HCV test kit is intended only for professional use as the initial test, as an aid to diagnosis. Reactive specimens should be followed up with nucleic acid testing (NAT) for the detection of HCV RNA together with a HCV immunoblot testing to identify current HCV infection. This test may not be suitable for diagnosis of early infection or blood donation screening.