SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0471-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First Response Syphilis Anti-TP Card Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Syphilis 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
Syphilis
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
PI08FRC100
Test kit package size
100
Test Package Size
PI08FRC25 (25 pcs each except for 1x IFU and 1x buffer bottle)
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
Identification name
PI08FRC25
Test kit package size
25
Test Package Size
PI08FRC25 (25 pcs each except for 1x IFU and 1x buffer bottle)
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
Identification name
PI08FRC50
Test kit package size
50
Test Package Size
PI08FRC25 (25 pcs each except for 1x IFU and 1x buffer bottle)
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
PI08FRC50 (50 pcs each except for 1x IFU and 2x buffer bottle)
PI08FRC100 (100 pcs each except for 2x IFU and 4x buffer bottle)
test device
desiccant
specimens transfer device
assay buffer bottle
sterile single use lancet
alcohol swab
IFU
IVD Manufacturing Site(s)
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India