SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0387-051-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
HCV Hepatitis C Virus Rapid Test Device (Whole blood/Serum/Plasma)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HCV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
ABON Biopharm (Hangzhou) CO.,LTD
#198 12th Street East, Hangzhou Economic & Technological Development Area
Hangzhou,
310018
China
Pathogen
HCV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
IHC-402WA
Test kit package size
40
Test Package Size
test device
buffer bottle
specimen dropper
IFU
buffer bottle
specimen dropper
IFU
Identification name
IHC-402WB
Test kit package size
25
Test Package Size
test device
buffer bottle
specimen dropper
IFU
buffer bottle
specimen dropper
IFU
Identification name
IHC-402WC
Test kit package size
40
Identification name
IHC-402WD
Test kit package size
25