SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0470-074-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
One Step test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II 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
RPWMPH-02
Test kit package size
10
Test Package Size
Assay Buffer Bottle
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
Identification name
RPWMPH-03
Test kit package size
25
Test Package Size
Assay Buffer Bottle
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
Identification name
RPWMPH-04
Test kit package size
50
Test Package Size
Assay Buffer Bottle
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
Specimen Transfer Devices
Alcohol Swabs
Lancets
Pack Insert
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