SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0357-004-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
One Step HIV1/2 Whole Blood/Serum/Plasma Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Guangzhou Wondfo Biotech Co., Ltd
8 Lizhishan Road, Science City, Luogang District
Guangzhou,
510530
China
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
W006-C4P2
Test kit package size
25
Test Package Size
25 x Device pouches, 1 x Buffer bottle, and 1 x IFU
Identification name
W006-C4P2-F
Test kit package size
40
Test Package Size
40 x Device pouch, 2 x Buffer bottles, 1 x IFU, 40 x Alcohol swabs, and 40 x Sterile lancets
Identification name
W006-P0045
Test kit package size
25
Test Package Size
25 x Device pouches, 1 x Buffer bottle, 1 x IFU, 25 x Alcohol swabs, and 25 x Sterile lancets
Identification name
W006-P0046
Test kit package size
25
Test Package Size
25 x device pouches, 1 x Buffer bottle, 1 x IFU, 25 x Alcohol swabs, and 12 x Safety lancets (18G)
Identification name
W006-P0047
Test kit package size
25
Test Package Size
25 x Device pouches, 1 x Buffer bottle, 1 x IFU, 25 x Alcohol swabs, and 25 x Safety lancets (25G)
Identification name
W006-P0048
Test kit package size
25
Test Package Size
15 x Device pouches, 1 x Buffer bottle, 1 x IFU, 25 x Alcohol swabs, and 25 x Safety lancets (23G)
Identification name
W006-P0049
Test kit package size
40
Test Package Size
40 x Device pouches, 2 x Buffer bottles, 1 x IFU, 40 x Alcohol swabs, and 40 x Sterile lancets
Identification name
W006-P0050
Test kit package size
40
Test Package Size
40 x Device pouches, 2 x Buffer bottles, 1 x IFU, 40 x Alcohol swabs, and 40 x Safety lancets (18G)
Identification name
W006-P0051
Test kit package size
40
Test Package Size
40 x Device pouches, 2 x Buffer bottles, 1 x IFU, 40 x Alcohol swabs, and 40 x Safety lancets (21G)
Identification name
W006-P0052
Test kit package size
40
Test Package Size
40 x Device pouches, 2 x Buffer bottles, 1 x IFU, 40 x Alcohol swabs, and 40 x Safety lancets (23G)
IVD Manufacturing Site(s)
Guangzhou Wondfo Biotech Co., Ltd
8 Lizhishan Road, Science City, Luogang District
Guangzhou,
510530
China