Manufacturer's By Device Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)-Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Korea Inc.65
Borahagal-Ro Giheung-Gu
Gyeonggi-Do
Yongin-Si 17099

South Korea
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
03/30/202113027
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
DiaSorin Molecular LLC11331 Valley View St.

Cypress
California 90630

United States
DiaSorin S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

United Kingdom
12/07/202120351
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
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
NovaTec Immundiagnostica GmbHWaldstrasse 23 A6

Dietzenbach
63128 Dietzenbach

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

England United Kingdom
04/13/202221663
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
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