Abbott Diagnostics Korea Bioline™ HCV
- Registration number
- DE0510686
- Model name
- Bioline™ HCV
- Model identifier
- 02FK10CE
- Registration date
- May 06, 2025
- Risk class
- Class D
- Product owner
- Abbott Diagnostics Korea Inc.
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 address
- 65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, Korea, South
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.