SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0360-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD Q HCV Ab Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HCV 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
HCV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
09HCV10D
Test kit package size
25
Test Package Size
1 test x 25 test device/kit (test device)
1 bottle of 4ml/kit (assay diluent)
1 pack of 25 ea/kit (capillary tube 20ul)
1 bottle of 4ml/kit (assay diluent)
1 pack of 25 ea/kit (capillary tube 20ul)
IVD Manufacturing Site(s)
Bionote, Inc (SD Biosensor)
34 Samsung 1ro 4-gill
Hwaseong-si, Gyeongggi-do,
18449
Republic of Korea