Roche Diagnostics
The diagnostics division of Roche, a global leader in in-vitro diagnostics and laboratory testing.
Updated Jul 1, 2026
Headquartered in Rotkreuz, Switzerland
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Overview
About Roche Diagnostics
Roche Diagnostics is the diagnostics division of the Roche Group (headquartered in Basel, Switzerland, and publicly traded on the SIX Swiss Exchange), with its own operational headquarters and R&D center in Rotkreuz, Switzerland. It manufactures in-vitro diagnostic systems, laboratory testing instruments, and point-of-care testing devices used by laboratories and hospitals worldwide.
Products
- In-vitro diagnostic systems (cobas platform)
- Laboratory testing instruments
- Point-of-care testing devices
- Molecular & companion diagnostics
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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IVDR
The EU regulation governing in vitro diagnostic devices — the IVD counterpart to the MDR.
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Related
Regulatory Pathways
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