SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0291-025-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
parascreen - Rapid test for Malaria Pan/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
503030025(1T)
Test kit package size
25
Test Package Size
Pouch sealed test with desiccant and specimen transfer device, 25 x 1 ml Assay buffer bottle, 25 x alcohol swabs, 25 x sterile lancets, 25 x Instructions for Use (IFU), and 25 x Pictorial IFU
Identification name
503030010
Test kit package size
10
Test Package Size
10 x Pouch sealed test with desiccant and
specimen transfer device, 1 x 3
specimen transfer device, 1 x 3
Identification name
503030025
Test kit package size
25
Test Package Size
25 x Pouch sealed test with desiccant
and specimen transfer device, Assay buffer bottle (1 bottle, total volume 4
and specimen transfer device, Assay buffer bottle (1 bottle, total volume 4
Identification name
503030050
Test kit package size
50
Test Package Size
50 x Pouch sealed test with desiccant and
specimen transfer device, 2 x Assay buffer bottles of 8
specimen transfer device, 2 x Assay buffer bottles of 8
Identification name
503030100
Test kit package size
100
Test Package Size
100 x Pouch sealed test with desiccant
and specimen transfer device, 2 x 8
and specimen transfer device, 2 x 8
IVD Manufacturing Site(s)
Zephyr Biomedicals – A Division of Tulip Diagnostics (P) Ltd.
M 46-47, Phase III B, Verna,
Goa,
403722
India