Manufacturer's By Device Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)-Clostridium difficile 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 Limited (a subsidiary of Kilpest India Limited)7-C Industrial Area Govindpura
Bhopal
Bhopal
462023

India
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
05/16/202224647
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
Abacus DiagnosticaTykistökatu 4D

Turku
FI-20520

Finland
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
01/18/202221303
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
Amplex Diagnostics GmbHWerkstr. 2

Gars-Bahnoff
83555

Germany
Pro-Lab Diagnostics3 Bassendale Road

Bromborough
Wirral CH62 3QL

England United Kingdom
08/17/202225535
Becton Dickinson and Company (BD)7 Loveton Circle

Sparks
Maryland 21152

United States
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
09/09/202117321
Cepheid ABRöntgenvägen 5

Solna
171 54

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

England United Kingdom
08/02/202112004
Clonit SrlVia Lombardia 6

Siziano
27010

Italy
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
12/10/202120449
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
ELITechGroup S.p.AC.co Svizzera 185

Torino
10149

Italy
ELITech UK LTD6 River Park Industrial Estate Billet Lane

Berkhamsted
Hertfordshire HP41HL

United Kingdom
04/19/202212297
GeneReach Biotechnology Corp.No.19 Keyuan 2nd Road
Xitun Dist.
Taichung City 407
407

Taiwan
HORIBA UK LimitedKYOTO CLOSE MOULTON PARK

NORTHAMPTON
Northants NN3 6FL

United Kingdom
04/15/202221707
Luminex Corporation12212 Technology Blvd

Austin
Texas 78727

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

Dartford
DA1 5LR

United Kingdom
12/29/202121515
Meridian Bioscience Inc.3471 River Hills Drive

Cincinnati
OH 45244

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
09/08/202117346
Mobidiag OyKeilaranta 16A

Espoo
FI-02150

Finland
Mobidiag UK LtdHerschel House 58 Herschel Street

Slough
Berkshire SL1 1PG

England United Kingdom
01/07/202220522
Quidel Corporation2005 East State Street Suite 100

Athens OH
45701

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
02/25/202223263
Quidel Corporation10165 McKellar Ct.

San Diego CA
92121

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
02/25/202223264
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
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
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
Serosep LimitedSerosep Limited Annacotty Business Park

Annacotty
V94 FF83

Ireland
Serosep UK Ltd14 The Brunel Centre Newton Way

Crawley
RH10 9TU

United Kingdom
02/28/202223301
Shenzhen Uni-medica Technology Co. LtdRoom 202 Block 6th LiuXian Culture Park XiLi Town NanShan District

Shenzhen
Guangdong Province 518000

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/17/202225540