SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0383-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD Q HIV 1/2 Ab 3-Line Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
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
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
09HIV30D
Test Package Size
09HIV30D
25 test devices
bottle of assay diluent
capillary tubes
alcohol swabs
lancets
IFU
09HIV30DM
25 test devices
bottle of assay diluent
IFU
25 test devices
bottle of assay diluent
capillary tubes
alcohol swabs
lancets
IFU
09HIV30DM
25 test devices
bottle of assay diluent
IFU
Identification name
09HIV30DM
Test Package Size
09HIV30D
25 test devices
bottle of assay diluent
capillary tubes
alcohol swabs
lancets
IFU
09HIV30DM
25 test devices
bottle of assay diluent
IFU
25 test devices
bottle of assay diluent
capillary tubes
alcohol swabs
lancets
IFU
09HIV30DM
25 test devices
bottle of assay diluent
IFU