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HSA · registration DE0510686

Abbott Diagnostics Korea Bioline™ HCV

SingaporeImmunologyClass DAbbott Diagnostics Korea Inc.
Official record identity
Registration number
DE0510686
Model name
Bioline™ HCV
Model identifier
02FK10CE
Registration date
May 06, 2025
Classification
Risk class
Class D
Official value: CLASS D
Published category
Immunology
Published parties
Official 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.

Additional source fields
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
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.