SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0363-010-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
First Response HIV 1-2.O Card test Version 2.0
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV 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
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
PI05FRC100
Test kit package size
100
Identification name
PI05FRC10s
Test kit package size
10
Identification name
PI05FRC25
Test kit package size
25
Identification name
PI05FRC25s
Test kit package size
25
Identification name
PI05FRC30
Test kit package size
30
Identification name
PI05FRC50
Test kit package size
50
Identification name
PI05FRC60
Test kit package size
60
IVD Manufacturing Site(s)
Premier Medical Corporation Private Limited
32-33 Shri Ganesh Industrial Estate
Kachigam,
396215
India