SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0544-005-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
HIV SELF TEST BY URINE – Human Immunodeficiency Virus (HIV) type-I urine antibody diagnostic kit (colloidal gold)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV self-test
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (English version_for history purposes only)
No.31 Kexueyuan Road, Changping District
Beijing,
102206
China
Pathogen
HIV
Specimen Type
Urine
Product Code
Identification name
WZ-1001
Test kit package size
1
Test Package Size
WZ-1001
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50
Identification name
WZ-1010
Test kit package size
10
Test Package Size
WZ-1001
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50
Identification name
WZ-1050
Test kit package size
50
Test Package Size
WZ-1001
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50
test cassette x1
plastic pipette x1
urine cup x1
WZ-1010
test cassette x10
plastic pipette x10
urine cup x10
WZ-1050
test cassette x50
plastic pipette x50
urine cup x50