SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0054-006-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
SURE CHECK HIV 1/2 Assay
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford,
11763
United States of America
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
HIV201(60-9527-0)
Test kit package size
25
Test Package Size
25 pouches, with each pouch containing 1 test device, 1 specimen transfer device, 1 bottle of buffer (~350 μl), 1 sterile lancet, 1 bandage, and 1 desiccant packet;
1 instructions for use;
1 disposable rack for holding buffer vials upright;
1 insert for the Disposable Rack
1 instructions for use;
1 disposable rack for holding buffer vials upright;
1 insert for the Disposable Rack
IVD Manufacturing Site(s)
Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford,
11763
United States of America