SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0285-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First Response Malaria Ag. pLDH/HRP2 Combo Card Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
PI16FRC10s
Test kit package size
10
Identification name
PI16FRC25
Test kit package size
25
Identification name
PI16FRC25s
Test kit package size
25
Identification name
PI16FRC30
Test kit package size
30
IVD Manufacturing Site(s)
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India