Manufacturer's By Device HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control-HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
National Institute for Biological Standards and Control (NIBSC)Blanche Lane South Mimms

Potters Bar
Hertfordshire EN6 3QG

United Kingdom





02/07/20172
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
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
Seracare Life Sciences 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