SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0149-052-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Uni-Gold 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 (venous)
Product Code
Identification name
1206502
Test kit package size
20
Test Package Size
Kit contains:
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
Identification name
1206502E
Test kit package size
20
Test Package Size
Kit contains:
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
Identification name
1206502N
Test kit package size
20
Test Package Size
Kit contains:
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
20 Test Devices
Wash Reagent (2 ml) Single reagent for whole blood, serum or plasma
IVD Manufacturing Site(s)
ABON Biopharm (Trinity Biotech)
#198 12th Street East, Hangzhou Economic & Technological Development Area
Hangzhou,
310018
China
ABON Biopharm (Hangzhou) CO.,LTD
#198 12th Street East, Hangzhou Economic & Technological Development Area
Hangzhou,
310018
China