Manufacturer's By Device Creatine kinase myocardial isoenzyme (CKMB) IVD control-Creatine kinase myocardial isoenzyme (CKMB) IVD control

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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
05/09/202312578
Abbott Laboratories Diagnostics DivisionLake County Site 100 Abbott Park Road Abbott Park

Illinois
Illinois 60064

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202219226
Abbott Point of Care400 College Road East

Princeton
New Jersey 08540

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
01/31/202222502
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Boditech Med Inc.43 Geodudanji 1-gil Dongnae-myeon Chuncheon-si Gang-won-do 24398 Republic of Korea

Chuncheon-si
24398

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
05/24/202328282
CITEST DIAGNOSTICS INC170-422 Richards Street Vancouver BC
V6B 2Z4 Canada
Vancouver
V6B 2Z4

Canada
UK RepMed Ltd.Wey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT

England United Kingdom
08/11/202116644
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Getein Biotech Inc.No.9 Bofu Road Luhe District

Nanjing
211505

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
02/09/202222849
Glenbio Ltd.10 Kilbegs Road

Antrim
Co. Antrim BT41 4NN

Northern Ireland United Kingdom





08/28/20157208
Guangzhou Wondfo Biotech Co. Ltd.No.8 Lizhishan Road Science City Luogang District

Guangzhou
510663

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/07/202112536
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
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
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/10/202116678
Shenzhen New Industries Biomedical Engineering Co. Ltd.No.23 Jinxiu East Road Pingshan District

Shenzhen
518122

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202216793
Thermo Fisher Scientific OyRatastie 2

Vantaa
Uusimaa 01620

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

England United Kingdom
07/12/202225260