SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0651-004-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Wondfo Malaria P.f (HRP2/pLDH) Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Guangzhou Wondfo Biotech Co., Ltd
8 Lizhishan Road, Science City, Luogang District
Guangzhou,
510530
China
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
W037P0022
Test kit package size
25
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0024
Test kit package size
40
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0028
Test kit package size
25
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0030
Test kit package size
25
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0033
Test kit package size
40
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0035
Test kit package size
40
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide
Identification name
W037P0037
Test kit package size
100
Test Package Size
multi kits with test cassette, dessicant pouch, buffer (multi and single vial) invertec cup, IFU, alcool swab, sterile lancet, blood lancet and Quick guide