SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0267-037-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Diagnostic Kit for HIV(1+2) Antibody (Colloidal Gold) V2
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Shanghai Kehua Bio-engineering Co., Ltd.
1189 North Qinzhou Road, Caohejing Hi-Tech Park, Xuhui District
Shanghai,
200233
China
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (venous)
Product Code
Identification name
A-GOLD-01
Test kit package size
50
Identification name
KH-R-02
Test kit package size
50
Identification name
R-401-50-C-2
Test kit package size
50
Identification name
KH-R-03
Test kit package size
50
Test Package Size
2 bottles of sample diluent
Identification name
R-401-50-C-3
Test kit package size
50
Test Package Size
50 test cassettes
2 bottles of sample diluent
50 safety lancets
50 alcohol pads
50 disposable transfer pipettes
2 bottles of sample diluent
50 safety lancets
50 alcohol pads
50 disposable transfer pipettes
IVD Manufacturing Site(s)
Shanghai Kehua Bio-engineering - Warehouse
388 Mingfa Road Song Jiang District
Shanghai,
China
Shanghai Kehua Bio-engineering Co., Ltd.
1189 North Qinzhou Road
Shanghai,
200233
China