SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0294-074-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
One Step test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Meril Diagnostics Pvt. Ltd.
D1-D3, Meril Park, Survey No: 135/2/B & 174/2, Muktanand Marg, Chala
Vapi,
396191
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
MFLRPD-02
Test kit package size
30
Test Package Size
30 x Cassette packaging, each
containing 1 device and 1
desiccant, 2 x 3
containing 1 device and 1
desiccant, 2 x 3
Identification name
MFLRPD-03
Test kit package size
25
Test Package Size
25 x Cassette packaging, each
containing 1 device and 1
desiccant, 2 x 3
containing 1 device and 1
desiccant, 2 x 3
Identification name
MFLRPD-04
Test kit package size
50
Test Package Size
50 x Cassette packaging, each
containing 1 device and 1
desiccant, 4 x 3
containing 1 device and 1
desiccant, 4 x 3
Identification name
MFLRPD-05
Test kit package size
10
Test Package Size
10 x Cassette packaging, each
containing 1 device and 1
desiccant, 1 x 3
containing 1 device and 1
desiccant, 1 x 3
IVD Manufacturing Site(s)
Meril Diagnostics Pvt. Ltd.
D1-D3, Meril Park, Survey No: 135/2/B & 174/2, Muktanand Marg, Chala
Vapi,
396191
India