Illumina

About

Illumina is a global leader in DNA sequencing and array-based technologies. They develop and manufacture systems and reagents used in genomic research, diagnostics, and applied markets. Illumina is headquartered in the United States.

Illumina’s diagnostic products are regulated by the FDA in the United States. They adhere to FDA 21 CFR Part 820 for quality system regulation. Some of their products require premarket approval (PMA) or 510(k) clearance.