SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0027-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline HIV1/2 3.0
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV 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
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
03FK10
Test kit package size
30
Identification name
03FK16
Test kit package size
25
Identification name
03FK17
Test kit package size
25
Test Package Size
25 test devices, 1 x 4ml/bottle Assay diluent, 25 units of 20 μl specimen transfer devices, 25 units alcohol swabs, and 1 x IFU
IVD Manufacturing Site(s)
Standard Diagnostics, Inc - Site 2_Hagal Factory
65, Borahagal-ro, Giheung-gu
Yongin-si, Gyeonggi-do,
17099
Republic of Korea
Standard Diagnostics Korea 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