SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0329-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First ResponseMalaria Ag. P.f. / P.v. Card Test
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
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
PI19FRC10s
Test kit package size
10
Identification name
PI19FRC25
Test kit package size
30
Identification name
PI19FRC25s
Test kit package size
25
Identification name
PI19FRC30
Test kit package size
30
IVD Manufacturing Site(s)
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India