SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0320-090-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Mylan 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
Atomo Diagnostics Ltd
Level 1,3-5 George Street
Leichhardt,
NSW 2040
Australia
Pathogen
HIV
Specimen Type
Whole blood (capillary)
Product Code
Identification name
ARST001-03
Test kit package size
1
Test Package Size
1 IFU (Trilingual), Mylan HIV Self Test (in a foil packet with desiccant), Bottle of Test Fluid (Diluent) (2ml), Alcohol wipe and disposable bag
Identification name
ARST001-03-01
Test kit package size
1
Test Package Size
1 IFU (Trilingual), Mylan HIV Self Test (in a foil packet with desiccant), Bottle of Test Fluid (Diluent), Alcohol wipe and disposable bag
Identification name
ARST001-03-02
Test kit package size
1
Test Package Size
1 IFU (English), Mylan HIV Self Test (in a foil packet with desiccant), Bottle of Test Fluid (Diluent) (2ml), Alcohol wipe and disposable bag
Identification name
ARST001-03-03
Test kit package size
1
Test Package Size
1 IFU (English), Mylan HIV Self Test (in a foil packet with desiccant), Bottle of Test Fluid (Diluent) (2ml), Alcohol wipe and disposable bag
Identification name
ARST001-03-XX
Test kit package size
1
Test Package Size
1 IFU (English + regional language), Mylan HIV Self Test (in a foil packet with desiccant), Bottle of Test Fluid (Diluent) (2ml), Alcohol wipe and disposable bag
IVD Manufacturing Site(s)
Atomo Diagnostics Ltd
Level 1,3-5 George Street
Leichhardt,
NSW 2040
Australia