SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0661-265-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Asante HIV-1/2 Oral Fluid Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Sedia Biosciences Corporation
9590 SW Gemini Drive
Beaverton,
97008
United States of America
Pathogen
HIV
Specimen Type
Oral fluid
Product Code
Identification name
1502-100
Test Package Size
100x - Oral Swabs (PN 3094)
100x - Capped tubes containing Sample Buffer (PN 3099)
100x- Test Strips sealed in foil pouches with desiccant (PN 3092)
1x - Reusable foam tube holder (PN 7122)
1x- product insert (LN 6263)
100x - Capped tubes containing Sample Buffer (PN 3099)
100x- Test Strips sealed in foil pouches with desiccant (PN 3092)
1x - Reusable foam tube holder (PN 7122)
1x- product insert (LN 6263)