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ISO 13485: 2016

Roche Molecular Systems, Inc.
1080 US Highway 202 South
Branchburg
08876
USA

Certificate Number: MD 739945
Scope: Design and manufacture of In Vitro Diagnostic Kits, integrated systems and associated software used in the diagnosis and management of disease status of infectious diseases, donor screening associated with infectious diseases, primary screening associated with oncogenic viruses, detection of biomarkers for companion diagnostics, microbiology, and genetic testing.

Original Registration Date	Effective Date	Last Revision Date	Expiry Date
2021-03-05	2024-07-01	2024-06-04	2027-06-30

Site Name	Site Address	Certificate/License number	Standard/Scheme number or name
Roche Molecular Systems, Inc	4300 Hacienda Drive Pleasanton USA	MD 739945	ISO 13485: 2016
Roche Molecular Systems, Inc.	1080 US Highway 202 South Branchburg USA	MD 739945	ISO 13485: 2016
Roche Molecular Systems, Inc.	2 Millennium Way Branchburg USA	MD 739945	ISO 13485: 2016