SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0007-006-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
HIV 1/2 STAT-PAK
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
HIV101
Test kit package size
20
IVD Manufacturing Site(s)
Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford,
11763
United States of America