Manufacturer's By Device Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)-Cytomegalovirus (CMV) 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 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
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
BIONEER Corporation8-11 Munpyeongseo-ro

Daedeok-gu
Daejeon 34302

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

Oxford
OX1 2EP

England United Kingdom
01/18/202213753
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
GeneProof a.s.101/119 Dolní Heršpice
Vídeská Brno
Brno-msto
Jihomoravský kraj 619 00

Czechia
Pathway Diagnostics LtdEclipse House Curtis Road

Dorking
Surrey RH4 1EJ

United Kingdom
05/19/202224319
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
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
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
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
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
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
Vela Operations Singapore Pte. Ltd.#05-07 The Kendall 50 Science Park Road

Singapore
117406

Singapore
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
03/29/202223899