Manufacturer's By Device SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)-SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
AESKU.Diagnostics GmbH & Co. KGAESKU.Diagnostics GmbH & Co. KG Mikroforum Ring 2

Wendelsheim
55234

Germany
Aesku UK Limited483 Green Lanes
London
London
--- N13 4BS

United Kingdom
04/27/202113980
Autobio Diagnostics Co. LtdNo. 87 Jingbei Yi Road National Eco & Tech Development Area

Zhengzhou
450016

China
Chirus LimitedGreenhill House 26 Greenhill Crescent
Watford Business Park
Watford
Hertfordshire WD18 8JA

England United Kingdom
09/01/202116792
Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.No. 31 Kexueyuan Road Changping District

Beijing
102206

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/02/202221394
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
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
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