SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0179-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline HIV/Syphilis Duo
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV/Syphilis Combo RDT
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
HIV
Syphilis
Specimen Type
Plasma
Serum
Whole blood (venous)
Product Code
Identification name
06FK30
Test kit package size
25
Identification name
06FK35
Test kit package size
25
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
Standard Diagnostics Korea Inc. - Warehouse
28-1 Dongtan Industrial Complex (Sangwon Logistic),
Dongtan-myeon,
446-930
Republic of Korea
Standard Diagnostics, Inc - Site 2_Hagal Factory
65, Borahagal-ro, Giheung-gu
Yongin-si, Gyeonggi-do,
17099
Republic of Korea