SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0382-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD Q HIV/Syphilis Combo Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV/Syphilis Combo RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
SD Biosensor, Inc.
16 Deogyeong-daero, 155 beon-gil, Geonggi-do
Suwon-si,
16690
Republic of Korea
Pathogen
HIV
Syphilis
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
09HIV20D
Test Package Size
test devices
assay diluant
capillary tubes
alcohol swabs
lancets
IFU
assay diluant
capillary tubes
alcohol swabs
lancets
IFU