SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0469-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First Response HCV Card Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HCV serology
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
HCV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
PI03FRC100
Test kit package size
100
Test Package Size
test device pouch containing test device and desiccant (25, 50, 100 tests/kit)
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU
Identification name
PI03FRC25
Test kit package size
25
Test Package Size
test device pouch containing test device and desiccant (25, 50, 100 tests/kit)
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU
Identification name
PI03FRC50
Test kit package size
50
Test Package Size
test device pouch containing test device and desiccant (25, 50, 100 tests/kit)
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU
specimens transfer device (25, 50, 100 /tests/kit)
assay buffer bottle (bulk) (1, 2, 4 per 25, 50, 100 test/kit configuration)
sterile single-use lancet (25, 50, 100 /tests/kit)
alcohol swab (25, 50, 100 /tests/kit)
IFU