SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0030-012-01
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Bioline Malaria Ag P.f/Pan
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
Plasma
Serum
Whole blood (venous)
Product Code
Identification name
05FK60
Test kit package size
25
Test Package Size
Contains:
Test device individually foiled pouched with a desiccant
Assay dilutent
Disposable sample applicator (5ul), lancet (option), alcohol swab (option)
Instruction for use
Test device individually foiled pouched with a desiccant
Assay dilutent
Disposable sample applicator (5ul), lancet (option), alcohol swab (option)
Instruction for use
Identification name
05FK63
Test kit package size
25
Test Package Size
25x 1 test device, 25 x 180µl/vial Assay diluent, 25 pouches each containing one specimen transfer device (5μl), one lancet, one alcohol swab, 1 x IFU, and 25 Summarised Instructions for Use
Identification name
05FK61
Test kit package size
25
Test Package Size
25 test devices, 1 x 5ml/bottle Assay diluent, 25 units of 5μl specimen transfer devices, 25 units (safety lancets), and 1 x IFU
Identification name
05FK62
Test kit package size
25
Test Package Size
25x 1 test device, 25x 180µl/vial Assay diluent, 25 pouches each containing one specimen transfer device (5μl), one safety lancet, one alcohol swab, 1 x IFU, and 25 copies Summarised IFU
Identification name
05FK67
Test kit package size
30
Test Package Size
30 test devices, 30x 180µl/vial Assay diluent, 30 units of 5μl specimen transfer devices, 30 units of lancets, 30 units of alcohol swabs, and 1 x IFU