Illumina
The world's leading manufacturer of DNA sequencing and genomic diagnostics systems.
Updated Jul 1, 2026
Headquartered in San Diego, California, United States
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Overview
About Illumina
Illumina is headquartered in San Diego, California, and publicly traded on the Nasdaq. It manufactures next-generation DNA sequencing instruments and reagents used in genomic research, clinical diagnostics, and reproductive health testing worldwide.
Products
- Next-generation DNA sequencing systems
- Genomic diagnostics reagents & consumables
- Microarray-based genotyping systems
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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