SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0121-043-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HBV 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
HBV
Specimen Type
Plasma
Serum
Product Code
Identification name
2G27-01
Test kit package size
50
Identification name
9F80-01
Test kit package size
96
Identification name
9F80-05
Test kit package size
480
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