SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0257-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline HCV (formerly SD BIOLINE HCV)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HCV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.)
156-68, Hagal-dong
Giheung-ku, Yongin-si, Kyonggi-do,
Gyeonggi-do
446-930
Republic of Korea
Pathogen
HCV
Specimen Type
Plasma
Serum
Whole blood (venous)
Product Code
Identification name
02FK10
Test kit package size
30
IVD Manufacturing Site(s)
Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.)
156-68, Hagal-dong
Giheung-ku, Yongin-si, Kyonggi-do,
Gyeonggi-do
446-930
Republic of Korea