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98/79/EC Annex IV Ex. 4&6 (H7)

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

Certificate Number: CE 707974
Scope: Design and manufacture of nucleic acid test kits for Donor Screening for HBV, HCV and HIV. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of disease status for HBV, HCV or HIV infected individuals. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of Cytomegalovirus in transplant patients and for detection of HCV, HBV, HIV-1, HIV-2 and Chlamydia Trachomatis.

Original Registration Date	Effective Date	Last Revision Date	Expiry Date
2019-03-26		2022-03-31	2025-05-26

Site Name	Site Address	Certificate/License number	Standard/Scheme number or name
Roche Molecular Systems, Inc.	1080 US Highway 202 South Branchburg USA	CE 707974	98/79/EC Annex IV Ex. 4&6 (H7)
Roche Molecular Systems, Inc.	2 Millennium Way Branchburg USA	CE 707974	98/79/EC Annex IV Ex. 4&6 (H7)