SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0364-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First Response HIV1+2/Syphilis Combo Card Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV/Syphilis Combo 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
HIV
Syphilis
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
I20FRC100
Identification name
I20FRC25
Identification name
I20FRC30
Identification name
I20FRC50
Identification name
I20FRC60
IVD Manufacturing Site(s)
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India