SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0297-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline Malaria Ag P.f/P.f/P.v (formerly SD BIOLINE Malaria Ag P.f/P.f/P.v)
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
05FK120
Test kit package size
25
Identification name
05FK123
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, Inc - Site 2
65, Borahagal-ro, Giheung-gu
Yongin-si, Gyeonggi-do,
17099
Republic of Korea