Manufacturer's By Device SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control-SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control

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Page(s) 1
Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Ireland Diagnostics DivisionFinisklin Business Park

Sligo
n/a

Ireland
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202212578
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

United States
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/19/202214139
Cliniqa Corporation495 Enterprise Street

San Marcos
California 92078

United States
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
06/13/202224799
DiaMex GmbHSiemensstra├če 38

Heidelberg
69123

Germany
AB Scientific LtdKemp House

London
EC1V 2NX

England United Kingdom
03/11/202223570
DiaSorin S.p.A.DiaSorin S.p.A.
Via Crescentino SALUGGIA
VC
Piemonte 13040

Italy
DiaSorin S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

United Kingdom
04/27/202113991
LGC Clinical Diagnostics Inc.37 Birch Street

Milford
Massachusetts 01757

United States
QCS International LTD.Suite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ

Scotland United Kingdom
04/30/202114302
Microgenics Corporation46500 Kato Road

Fremont
California CA 94538

United States
Thermo Fisher Diagnostics Ltd.16 Shenley Pavillions Chalkdell Drive
Shenley Wood
Milton Keynes
MK5 6LB

England United Kingdom
07/14/202225266
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
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom





05/01/20186486
Quotient Suisse SARoute de Crassier 13

Eysins
Vaud 1262

Switzerland
Alba Bioscience LimitedJames Hamilton Way

Penicuik
EH26 0BF

Scotland United Kingdom
03/26/202112981
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
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
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201532
Siemens Healthcare Diagnostics Inc511 Benedict Avenue

Tarrytown
NY 10591

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201534