SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0473-052-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
TrinScreen HIV
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Trinity Biotech Manufacturing Ltd
1 Southern Cross IDA Business Park
Bray,
County Wicklow
Ireland
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
5551100
Test kit package size
100
Test Package Size
100 x pouched device
wash solution 4x2ml
50x 2 bags (100 pcs total) lancet
50x 2 bags (100 pcs total) swabs
50 x 2 bags (100 pcs total) pipette
1x IFU
wash solution 4x2ml
50x 2 bags (100 pcs total) lancet
50x 2 bags (100 pcs total) swabs
50 x 2 bags (100 pcs total) pipette
1x IFU