Manufacturer's By Device SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)-SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3B BlackBio Biotech India Limited7-C Industrial Area Govindpura

Bhopal Madhya Pradesh
462023

India
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/06/202120343
Abbott Diagnostics Scarborough Inc.10 Southgate Rd

Scarborough
Maine 04074

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

England United Kingdom
07/08/202115830
Abbott Molecular Inc.1350 E. Touhy Ave

Des Plaines IL
Illinois 60018

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202213024
Abiores Technology (Beijing) Co. Ltd.No.8 Central Road Doudian Town
Fangshan District
Beijing
102433

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/12/202224169
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
Anatolia Tan ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AHasanpasa Mah. Beydagi Sk
No: 1-9 H
Istanbul
Sultanbeyli 34920

Turkey
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/28/202114050
Beijing Kinghawk Pharmaceutical Co. Ltd.No.7 Yuncheng Street BDA

Beijing
100176

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
05/24/202224422
BGI Europe A/SOle Maaløes Vej 3

Copenhagen
DK-2200

Denmark
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
09/07/202117963
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Bosch Healthcare Solutions GmbHStuttgarter Straße 130

Waiblingen
71332

Germany
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom
09/22/202117113
Cepheid Inc904 Caribbean Drive

Sunnyvale
CA 94089

United States
Cepheid UK LtdOakley Court Kingsmead Business Park
Frederick Place
High Wycombe
HP11 1JU

England United Kingdom
12/23/202121497
Department of Health and Social CareJuno Drive Axiom Building

Leamington Spa
Warwickshire CV31 3HH

England United Kingdom





07/10/202010307
Diagnostics for the Real World LtdDiagnostics for the Real World Ltd 845 Embedded Way suite 150

San Jose
CA 95138

United States
Diagnostics For The Real World (Europe) LtdSuite 12 Science Village
Chesterford Research Park
Little Chesterford
Essex CB10 1XL

United Kingdom
04/05/202212398
Diagnostics for the Real World Ltd845 Embedded Way Suite 150

San Jose
CA 95138

United States
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
09/07/202225721
Edinburgh Genetics Limited64a Cumberland Street

Edinburgh
EH3 6RE

Scotland United Kingdom
EG GENETICS LIMITEDMoat House 54 Bloomfield Ave

Belfast
BT5 5AD

Northern Ireland United Kingdom
04/15/202211340
Fast Track Diagnostics Luxembourg SARL29 rue Henri Koch Esch-sur-Alzette

Luxembourg
4354

Luxembourg
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
12/20/202120218
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Genedrive Diagnostics48 Grafton Street

Manchester
M139XX

United Kingdom





11/26/20199327
Genetic Analysis ASKabelgata 8

Oslo
0580

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

England United Kingdom
07/01/202225131
Hain Lifescience GmbHHardwiesenstr. 1
Nehren Württ
Landkreis Tübingen
Tübingen 72147

Germany
Bruker UK LimitedBanner Lane

Coventry
CV4 9GH

England United Kingdom
04/22/202212957
Hologic Inc.10210 Genetic Center Drive

San Diego
CA 92121

United States
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom
03/11/201669
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom





11/09/201768
Immundiagnostik AGStubenwald-Allee 8a

Bensheim
64625

Germany
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
05/24/202224733
Inno-train Diagnostik GmbHNiederhoechstaedter Str 62

Kronberg
D 61476

Germany
Sussex Biologicals LtdUnit H7/H8 Swallow Enterprise Park
Lower Dicker
Hailsham
East Sussex BN27 4EL

England United Kingdom
04/06/202113153
Kangmei Tianhong Biotech (Beijing) Co. Ltd. #16 No.1 Gaolizhang Road

Haidian Beijing
100095

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
01/10/202221131
KH Medical Co. Ltd.201 Jinwiseo-ro Jinwi-myeon

Pyeongtaek-si
Gyeonggi-do 17712

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

Oxford
OX1 2EP

England United Kingdom
05/07/202114540
Life Technologies Corporation6055 Sunol Blvd

Pleasanton
CA 94566

United States
Life Technologies Ltd3 Fountain Drive Inchinnan Business Park

Paisley
Renfrewshire PA4 9RF

United Kingdom
12/23/202121459
Luminex Corporation12212 Technology Blvd

Austin
Texas 78727

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

Dartford
DA1 5LR

United Kingdom
12/29/202121515
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





05/06/20209941
Mobidiag OyKeilaranta 16A

Espoo
FI-02150

Finland
Mobidiag UK LtdHerschel House 58 Herschel Street

Slough
Berkshire SL1 1PG

England United Kingdom
01/07/202220522
MOBILE DETECT BIO INC120 Industrial Blvd

Sugar Land
TX 77487

United States
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
01/06/202212699
Nanjing Liming Bio-Products Co. Ltd.No.12 Huayuan Road

Nanjing Jiangsu
210042

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/09/202011119
NeuMoDx Molecular1250 Eisenhower Pl Ann Arbor

Washtenaw
MI 48108-3281

United States
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/31/202213041
Nonacus LimitedBioHub Birmingham Research Park 97 Vincent Drive

Birmingham
West Midlands B15 2SQ

United Kingdom





12/07/202011077
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





07/13/202010323
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





07/13/202010323
Primerdesign LtdUnit 1 Watchmoor Point Watchmoor Road Camberley Surrey

Camberley
GU15 3AD

United Kingdom





08/04/20176351
Primerdesign LtdUnit 1 Watchmoor Point Watchmoor Road Camberley Surrey

Camberley
GU15 3AD

United Kingdom





08/04/20176351
QIAGEN GmbHQIAGEn GmbH
Qiagen Str. 1 Hilden
Mettmann
Düsseldorf 40724

Germany
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/19/202112724
QuantuMDx Group LtdLugano Building 57 Melbourne Street

Newcastle upon Tyne
NE1 2JQ

England United Kingdom





09/09/20229764
QuantuMDx Group LtdLugano Building 57 Melbourne Street

Newcastle upon Tyne
NE1 2JQ

England United Kingdom





09/09/20229764
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Sansure Biotech Inc.No. 680 Lusong Road Yuelu District

Changsha
Hunan Province 410205

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/28/202117610
Seegene Inc.Taewon Bldg. 91 Ogeum-ro Songpa-gu

Seoul
05548

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

Oxford
OX1 2EP

England United Kingdom
08/11/202116731
Shenzhen Huizhong Biotech Co. Ltd.B1 Xia Gu 101 Fengyeyuan Industrial Factory Xingdong Community
Xin'an Sub-district Bao'an District
Shenzhen
518101

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
09/21/202116707
The Doctors Laboratory LimitedThe Halo Building 1 Mabledon Place

London
WC1H 9AX

England United Kingdom





02/08/202112027
Trentron Biomedical Ltd.(Building A) 35F. No.99 Sec.1 Xintai 5th Road

New taipei city
Xizhi District 22175

Taiwan
Advena LtdPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom
07/06/202218086
UgenTec N.V.Kempische Steenweg 303/105

Hasselt
Limburg 3500

Belgium
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
12/31/202120989
Wallac OyMustionkatu 6

Turku
20750

Finland
Perkinelmer LtdChalfont Road Seer Green

Beaconsfield
Bucks HP9 2FX

United Kingdom
04/04/202220247
YOURGENE HEALTH UK LTDCitylabs 1.0 Nelson Street

Manchester
M13 9NQ

United Kingdom





02/14/20226929