SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0053-006-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
DPP 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
Oral fluid
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
65-9506-0
Test kit package size
20
Test Package Size
Kit contains:
20 DPP GIV 1/2 Individually Pouched Test Devices
20 Copies of Subject Information Notice
20 Oral Fluid Swabs
20 Disposable 10ul Sample Loops
20 DPP HIV SampleTainer (1ml) - Black Cap
1 DPP HIV Running Buffer (6ml) - Green Cap
1 Product Insert for the DPP HIV 1/2 Assay
20 DPP GIV 1/2 Individually Pouched Test Devices
20 Copies of Subject Information Notice
20 Oral Fluid Swabs
20 Disposable 10ul Sample Loops
20 DPP HIV SampleTainer (1ml) - Black Cap
1 DPP HIV Running Buffer (6ml) - Green Cap
1 Product Insert for the DPP HIV 1/2 Assay
IVD Manufacturing Site(s)
Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford,
11763
United States of America