SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0062-023-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
ParaHIT f Ver. 1.0 Rapid Test for P. falciparum Malaria Device
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
Arkray Healthcare Private Limited
Plot No. 336, 338,340, Road no. 3, G.I.D.C.
Sachin (Surat),
394230
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
55IC104-10
Identification name
55IC104-25
Identification name
55IC104-50
Identification name
55IC116-10
Test kit package size
10
Test Package Size
Test device x 10, Single-use inverted cup x 10, Reaction buffer 1 x 2
Identification name
55IC116-25
Test kit package size
25
Test Package Size
Test device x 25, Single-use inverted cup x 25, Reaction buffer 1 x 6 mL, Sterile lancets x 25, Alcohol swabs x 25, and IFU x 1
Identification name
55IC116-50
Test kit package size
50
Test Package Size
Test device x 50, Single-use inverted cup x 50, Reaction buffer 1 x 12 mL, Sterile lancets x 50, Alcohol swabs x 50, and IFU x 1
IVD Manufacturing Site(s)
Arkray Healthcare Private Limited
Plot no 336/338/340, Road no 3, G.I.D.C.
Sachin (Surat),
394230
India