Manufacturer's By Device SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control-SARS-CoV-2 immunoglobulin G (IgG) antibody 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
03/09/202112578
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

United States
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/29/202114139
Microgenics Corporation46500 Kato Road

Fremont CA USA
Ca 94538

United States
Life Technologies Ltd3 Fountain Drive Inchinnan Business Park

Paisley
Renfrewshire PA4 9RF

United Kingdom
05/05/202114441
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom





05/01/20186486
Quotient Suisse SARoute de Crassier 13

Eysins
Vaud 1262

Switzerland
Alba Bioscience LimitedJames Hamilton Way

Penicuik
EH26 0BF

United Kingdom
03/26/202112981
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Roche Diagnostics GmbHSandhofer Strasse 116

Mannheim
68305

Germany
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/19/202113524
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedSir William Siemens Square Frimley

Camberley
Surrey GU16 8QD

England United Kingdom
04/01/201532
Siemens Healthcare Diagnostics Inc511 Benedict Avenue

Tarrytown
NY 10591

United States
Siemens Healthcare Diagnostics LimitedSir William Siemens Square Frimley

Camberley
Surrey GU16 8QD

England United Kingdom
04/01/201534