Manufacturer's By Device Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)-Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Biohit OYJLaippatie 1

Helsinki
FI-00880

Finland
BIOHIT HealthCare LtdPioneer House Pioneer Business Park
North Road
Ellesmere Port
Cheshire CH65 1AD

England United Kingdom
06/22/202219851
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France
bioMérieux UK LtdChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom
03/30/202113038
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Dia.Pro Diagnostic Bioprobes S.r.l.27
Via Giosue Carducci SESTO SAN GIOVANNI
MI
Lombardia 20099

Italy
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/20/202113611
Diesse Diagnostica Senese SpaDiesse Diagnostica Senese Spa Sede Legale e Amm.ne
Via A. Solari 19 MONTERIGGIONI
MI
20144

Italy
IVDeology UKRP Ltd22-23 The Joiners Shop Historic Dockyard
Chatham
Rochester
Kent ME4 4TZ

England United Kingdom
07/14/202115944
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
IBL INTERNATIONAL GMBHFLUGHAFENSTRASSE 52A
FLUGHAFENSTRASSE 52A
HAMBURG
22335

Germany
Tecan UK LimitedTheale Court 11-13 High Street

Theale Reading
Berkshire RG7 5AH

England United Kingdom
01/05/202221763
INOVA Diagnostics9900 Old Grove Road

San Diego
CA 92131

United States
Werfen Ltd712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE

England United Kingdom
04/13/202221374
Meridian Bioscience Inc.3471 River Hills Drive

Cincinnati
OH 45244

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
09/08/202117346
NeoMedica dooBulevar Svetog Cara Konstantina 82-86

Nis
18103

Serbia
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
11/26/202011006
ORGENTEC Diagnostika GmbHCarl-Zeiss-Str. 49-51

Mainz
Rheinhessen-Pfalz 55129

Germany
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/20/202116853
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
VicTorch Meditek Inc.6888 Nancy Ridge Drive

San Diego
California 92121

United States
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
07/04/202225144
Vircell S.L.Parque Tecnológico de la Salud Avicena 8

Granada
18016

Spain
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
07/28/202115979
Virion\Serion GmbHFriedrich-Bergius-Ring 19

Wurzburg
97076

Germany
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
07/21/202116021