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0349-012-00

SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0349-012-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
NxTek Eliminate Malaria Ag P.f (formely Alere Malaria Ag P.f)
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
05FK140
Test kit package size
25
Test Package Size
05FK140
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 1 IFU)

05FK141
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 1 IFU)

05FK142
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 25 summarized IFU)

05FK143
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 25 summarized IFU)
Identification name
05FK141
Test kit package size
25
Test Package Size
05FK140
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 1 IFU)

05FK141
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 1 IFU)

05FK142
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 25 summarized IFU)

05FK143
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 25 summarized IFU)
Identification name
05FK142
Test kit package size
25
Test Package Size
05FK140
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 1 IFU)

05FK141
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 1 IFU)

05FK142
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 25 summarized IFU)

05FK143
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 25 summarized IFU)
Identification name
05FK143
Test kit package size
25
Test Package Size
05FK140
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 1 IFU)

05FK141
(25 test devices, 1 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 1 IFU)

05FK142
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 SAFETY lancets and 25 summarized IFU)

05FK143
(25 test devices, 25 assay diluent, 25 disposable specimen applicators, 25 alcohol swabs, 25 STERILE lancets and 25 summarized IFU)
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