SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0144-043-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Murex HIV Ag/Ab Combination
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
DiaSorin S.p.A - UK Branch
Central Road
Dartford,
Kent
DA1 5LR
United Kingdom of Great Britain and Northern Ireland
Pathogen
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
7G79-09
Test kit package size
96
Test Package Size
7G79-09 (96 tests) / 7G79-11 (480 tests)
Coated Wells: One plate / Five plates
Sample Diluent: 1 bottle of 8 ml / 1 bottle of 18 ml
Conjugate: 1 bottle of 1
Coated Wells: One plate / Five plates
Sample Diluent: 1 bottle of 8 ml / 1 bottle of 18 ml
Conjugate: 1 bottle of 1
Identification name
7G79-11
Test kit package size
480
Test Package Size
7G79-09 (96 tests) / 7G79-11 (480 tests)
Coated Wells: One plate / Five plates
Sample Diluent: 1 bottle of 8 ml / 1 bottle of 18 ml
Conjugate: 1 bottle of 1
Coated Wells: One plate / Five plates
Sample Diluent: 1 bottle of 8 ml / 1 bottle of 18 ml
Conjugate: 1 bottle of 1
IVD Manufacturing Site(s)
DiaSorin S.p.A - UK Branch
Central Road
Dartford,
Kent
DA1 5LR
United Kingdom of Great Britain and Northern Ireland
DiaSorin S.p.A - Italy
Via Crescentino, snc,
Saluggia,
13040
Italy