SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0372-017-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
ONE STEP Anti‐HIV (1&2) Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
ITPW02152- TC25
Test kit package size
25
Test Package Size
25 x Test cassettes, 25 x Droppers, 2ml x 3 bottles of Sample diluent, and 1 package insert
Identification name
ITPW02152- TC40
Test kit package size
40
Test Package Size
40 x Test cassettes, 40 x Droppers, ml x 4 bottles of Sample diluent, and 1 IFU
Identification name
ITPW02153- TC40
Test kit package size
40
Test Package Size
40 x Test cassettes, 40 x Droppers, 2mL x 4 bottles of Sample diluent, 40 x Sterile Safety Lancets, 40 x Alcohol swabs, and 1 IFU
Identification name
ITPW02153- TC40SA
Test kit package size
40
Test Package Size
40 x Test cassettes, 40 x Droppers, 2mL x 4 bottles of Sample diluent, 40 x Sterile Safety Lancets, 40 x Alcohol swabs, and 1 IFU
Identification name
ITPW02154- TC40
Test kit package size
40
Test Package Size
40 x Test cassettes, 40 x Droppers, 2mL x 4 bottles of Sample diluent, 40 x Sterile Safety Lancets, 40 x Alcohol swabs, and 1 IFU
IVD Manufacturing Site(s)
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China