SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0005-005-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
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
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
WJ-1810
Test kit package size
10
Identification name
WJ-1850
Test kit package size
50
Identification name
WJ-1810E
Test kit package size
10
Identification name
WJ-1850E
Test kit package size
50
Identification name
WJ-1810EL
Test kit package size
10
Identification name
WJ-18S10EL
Test kit package size
10
Identification name
WJ-1850EL
Test kit package size
50
Identification name
WJ-18S50EL
Test kit package size
50
Identification name
WJ-18S10ELC
Identification name
WJ18S50ELC
Test kit package size
50
IVD Manufacturing Site(s)
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (English version_for history purposes only)
No.31 Kexueyuan Road, Changping District
Beijing,
102206
China