Manufacturer's By Device SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay-SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Beijing Hotgen Biotech Co Ltd9th Building No 9 Tianfu Street Biomedical Base Daxing District

Beijing
102600

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
02/27/202112377
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom





05/01/20186486
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 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