SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0384-077-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
VISITECT CD4 Advanced Disease
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
CD4 technologies
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
AccuBio Ltd
Hillfoots Business Village
Alva,
FK12 5DQ
United Kingdom of Great Britain and Northern Ireland
Pathogen
HIV
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
AB376
Test kit package size
25
Test Package Size
foil pouch with: test device, dessicant sachet, sampling device
buffer
retractable lancet
alcohol swab
Job Aid for venous blood
Job Aid for capillary blood
IFU
buffer
retractable lancet
alcohol swab
Job Aid for venous blood
Job Aid for capillary blood
IFU
IVD Manufacturing Site(s)
AccuBio Ltd
Hillfoots Business Village
Alva,
FK12 5DQ
United Kingdom of Great Britain and Northern Ireland