SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0345-101-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
AdvDx Malaria Pf Rapid Malaria Ag Detection Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Advy Chemical Pvt Ltd.
Plot No.A-334,336,338 & A-337 & 339 Road No. 25 & 26, Wagle Industrial Estate
Thane,
400604
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
00-DKMRK- MALADX- 004- 025
Test kit package size
25
Test Package Size
25 x Test Devices (foil pouched with a desiccant), 25 x Sample applicators, 25 x Alcohol swabs, 1 x 3
Identification name
00-DKMRK- MALADX- 004- 050
Test kit package size
50
Test Package Size
50 x Test devices (individually pouched with desiccant), 50 x Sample applicators, 50 x Alcohol swabs, 50 x lancets, 3 x 3
Identification name
00-DKM-RK-MALADX- 004-001
Test kit package size
1
Test Package Size
1 x Test Device is individually foil-pouched with a desiccant, 1 x Sample applicator, 1 x Alcohol swab, 1 x lancets, 1 x 0
Identification name
00-DKMRK- MALADX- 004- 010
Test kit package size
10
Test Package Size
10 x Test Device (individually
foil-pouched with a desiccant), 10 x Sample applicators, 10 x Alcohol swabs, 10 x Lancets, 1 x 3
foil-pouched with a desiccant), 10 x Sample applicators, 10 x Alcohol swabs, 10 x Lancets, 1 x 3
Identification name
00-DKM-RK-MALADX- 004-001-010
Test kit package size
10
Test Package Size
Includes testing device, sample applicator, Alcohol swab, Lancet, bUFFUER Ampoule, and IFU
Identification name
00-DKM-RK-MALADX- 004-001-25
Test kit package size
25
Test Package Size
Includes Test device, Sample applicator, Alcohol swab, Lancet, Buffer ampoule, and IFU
IVD Manufacturing Site(s)
Advy Chemical Pvt Ltd.
Plot No.A-334,336,338 & A-337 & 339 Road No. 25 & 26, Wagle Industrial Estate
Thane,
400604
India