SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0627-017-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
ONE STEP Malaria (Pf/Pv) Tri-line Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
ITPW11009-TC25
Test kit package size
25
Test Package Size
25 x cassettes, 25 x droppers, 2 mL x 3 buffer bottles, 25 x lancets, 25 x alcohol swabs, and 1 x IFU
Identification name
ITPW11009-TC40
Test kit package size
40
Test Package Size
40 x cassettes, 40 x droppers, 2 mL x 4 buffer bottles, 40 x lancets, 40 x alcohol swabs, and 1 x IFU
Identification name
TPW11249-TC25
Test kit package size
25
Test Package Size
25 x cassettes, 25 x inverted cups, 2 mL x 3 buffer bottles, 25 x lancets, 25 x alcohol swabs, and 1 x IFU
Identification name
ITPW11249-TC40
Test kit package size
40
Test Package Size
40 x cassettes, 40 x inverted cups, 2 mL x 4 buffer bottles, 40 x lancets, 40 x alcohol swabs, and 1 x IFU
IVD Manufacturing Site(s)
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China