SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0330-074-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
One Step test for Malaria Pf/Pan Ag MERISCREEN Malaria Pf/Pan 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
MHLRPD-02
Test kit package size
30
Identification name
MHLRPD-03
Test kit package size
10
Test Package Size
10 x Test device (packaged with activated silica), 10 x specimen transfer devices (inverted cups), 1 x 3
Identification name
MHLRPD-04
Test kit package size
25
Test Package Size
25 x Test device (packed individually containing activated silica), 25 x specimen transfer devices (inverted cups), 2 x 3
Identification name
MHLRPD-05
Test kit package size
50
Test Package Size
50 x Test device (packaged in a pouch with activated silica), 50 x specimen transfer devices (inverted cup), 4 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