SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0481-032-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
CheckNOW HIV SELF TEST
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV self-test
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Loebstedter Str. 103-105
Jena,
7743
Germany
Pathogen
HIV
Specimen Type
Whole blood (capillary)
Product Code
Identification name
29012-W01
Test Package Size
1x test device
1x lancet
1x 3mL vial bottle of buffer
1x specimen dropper
2x alcohol pads
1x bandage (plaster)
1x IFU
1x lancet
1x 3mL vial bottle of buffer
1x specimen dropper
2x alcohol pads
1x bandage (plaster)
1x IFU