Singapore HSA registration DE0510686
Abbott Diagnostics Korea Bioline™ HCV
Singapore·CLASS D IVD·Abbott Diagnostics Korea Inc.·Registered May 06, 2025Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510686
- Registration Date
- May 06, 2025
- Retention Due Date
- May 05, 2026
Product description
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.
Product Owner
- Short Name
- Abbott Diagnostics Korea Inc.
- Address
- 65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, KOREA, REPUBLIC OF
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)
- Bioline™ HCV
- Model Identifier(s)
- 02FK10CE
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD