SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0219-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline HBsAg WB (formerly SD BIOLINE HBsAg WB)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HBV 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
HBV
Specimen Type
Plasma
Serum
Product Code
Identification name
01FK10W
Test kit package size
30
IVD Manufacturing Site(s)
Standard Diagnostics, Inc - Warehouse
28-1 Dongtan Industrial Complex (Sangwon Logistic),
Dongtan-myeon,
446-930
Republic of Korea
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
Standard Diagnostics, Inc - Site 2
65, Borahagal-ro, Giheung-gu
Yongin-si, Gyeonggi-do,
17099
Republic of Korea