SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0141-051-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/ Serum /Plasma)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
ABON Biopharm (Hangzhou) CO.,LTD
#198 12th Street East, Hangzhou Economic & Technological Development Area
Hangzhou,
310018
China
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
IHI-T402WB
Test kit package size
40
Test Package Size
40 x Pouched test devices with desiccant,40 x Sterile safety lancets, 40 x Specimen droppers (For Serum/Plasma/Venipuncture whole blood , 40 x sterile lancets, 2 x 3 mL Buffer, and 1 x IFU
Identification name
IHI-T402WA
Test kit package size
40
Test Package Size
40 x Pouched test devices with desiccant, 40 x specimen dropper, 2 x 3 mL Buffer and 1 x IFU
Identification name
IHI-T402WG
Test kit package size
40
Test Package Size
40 x Pouched test devices with desiccant,40 x Sterile safety lancets, 40 x Specimen droppers (For Serum/Plasma/Venipuncture whole blood, 40 x Alcohol swabs, 40 x specimen droppers, 2 x 3 mL, 1 x IFU
Identification name
IHI-T402WD
Test kit package size
10
Test Package Size
10 x Pouched test devices with desiccant, 10 x Sterile safety lancets, 10 x Specimen droppers (For Serum/Plasma/Venipuncture whole blood), 10 x Alcohol swabs, 10 x specimen droppers (For Fingerstick Whole Blood), 1 x 3 mL Buffer, and 1 x IFU
Identification name
IHIT402WE
Test kit package size
40
Test Package Size
40 x Test device, 40 x Alcohol swabs, 40 x Specimen Dropper (For Serum/Plasma/Venipuncture Whole Blood), 2 x 3 mL Buffer, 40 x Single-use lancets, 40 x Capillary Tube (For Fingerstick Whole Blood), and IFU
Identification name
IHI-T402WF
Test kit package size
10
Test Package Size
10 x Test device, 10 x Specimen Dropper (For Serum/Plasma/Venipuncture Whole Blood), 1 x 3 mL Buffer, 10 x Single-use lancets, 10 x Capillary Tube (For Fingerstick Whole Blood), and IFU
Identification name
IHIT402WI
Test kit package size
40
Test Package Size
40 x Test device, 40 x Specimen Dropper (For Serum/Plasma/Venipuncture Whole Blood), 2 x 3 mL Buffer, 40 x Single-use lancets, 40 x Capillary Tube (For Fingerstick Whole Blood), and IFU
IVD Manufacturing Site(s)
ABON Biopharm (Hangzhou) CO.,LTD
#198 12th Street East, Hangzhou Economic & Technological Development Area
Hangzhou,
310018
China