SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0290-025-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
FalciVax - Rapid test for Malaria Pv/Pf
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
Zephyr Biomedicals – A Division of Tulip Diagnostics (P) Ltd.
M 46-47, Phase III B, Verna,
Goa,
403722
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
503010010
Test kit package size
10
Identification name
503010025
Test kit package size
25
Identification name
503010050
Test kit package size
50
Identification name
503010100
Test kit package size
100
Identification name
503010025(1T)
Test kit package size
25
Test Package Size
Pouch-sealed test with desiccant and specimen transfer device (25 x 1T (25 single kit test/kit)), 25 x 1
IVD Manufacturing Site(s)
Zephyr Biomedicals – A Division of Tulip Diagnostics (P) Ltd.
M 46-47, Phase III B, Verna,
Goa,
403722
India