SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0209-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline Malaria Ag P.f (HRP2/pLDH)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
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
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
05FK90
Test kit package size
25
Identification name
05FK93
Test kit package size
25
Test Package Size
25 x 1 Test device, 25 x 180µl/vial Assay diluent, 25 packages each containing one specimen transfer device (5μl), one lancet, one alcohol swab, 1 x IFU, and 25 copies summarised IFUs
Identification name
05FK91
Test kit package size
25
Test Package Size
25 x Test devices, 1 x 5 mL Assay diluent, 25 units of 5μl specimen transfer devices,25 units x safety lancet, 25 x Alcohol swabs, and 1 x IFU
Identification name
05FK92
Test kit package size
25
Test Package Size
25 x 1 Test device, 25x 180µl/vial Assay diluent, 25 packages each containing one specimen transfer device (5μl), one safety lancet, one alcohol swab, 1 x IFU, and 25 x Summarised IFU
IVD Manufacturing Site(s)
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
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