Manufacturer's By Device SARS-CoV-2 nucleic acid IVD control-SARS-CoV-2 nucleic acid IVD control

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
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
DiaMex GmbHSiemensstra├če 38

Heidelberg
69123

Germany
AB Scientific LtdKemp House

London
EC1V 2NX

England United Kingdom
03/11/202223570
Exact Diagnostics LLCExact Diagnostics LLC 100 South Jones Street
Suite 100
Fort Worth
Texas 76104

United States
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202224262
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
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
Microbiologics INC200 Cooper Avenue North

Saint Cloud
Minnesota 56303

United States
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom
03/24/202112852
MicrobixMicrobix 265 Watline Ave.

Mississauga
Ontario L4Z 1P3

Canada
R-Biopharm Rhone LtdMazars 30 Old Bailey

London
EC4M 7AU

England United Kingdom
02/10/202221156
National Institute for Biological Standards and Control (NIBSC)Blanche Lane South Mimms

Potters Bar
Hertfordshire EN6 3QG

United Kingdom





02/07/20172
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





07/13/202010323
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
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
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
Vircell S.L.Parque Tecnol├│gico de la Salud Avicena 8

Granada
18016

Spain
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
07/28/202115979
Wallac OyMustionkatu 6

Turku
20750

Finland
Perkinelmer LtdChalfont Road Seer Green

Beaconsfield
Bucks HP9 2FX

United Kingdom
04/04/202220247