Cepheid
Molecular diagnostics manufacturer known for rapid, point-of-care PCR testing systems, part of Danaher Corporation.
Updated Jul 1, 2026
Headquartered in United States
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Overview
About Cepheid
Cepheid manufactures the GeneXpert molecular diagnostics platform used for rapid, point-of-care PCR testing in hospitals and laboratories, and is a diagnostics operating company of Danaher Corporation.
Products
- Molecular diagnostic systems
- Point-of-care PCR testing cartridges
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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Related
Regulatory Pathways
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