Regulatory and Quality Information

Illumina is a global company with worldwide design, manufacturing, sales, and distribution facilities. Several locations have recognized quality system certifications, such as ISO 13485 Certification. These sites engage in continuous improvement to quality programs.

Quality Management Systems

United States

Environmental Management System


Occupational Health and Safety Management System


Product Documentation

cBot Systems
HiSeq Systems
Infinium RoMA
iScan System
iSeq 100 System
MiniSeq System
MiSeq Systems
NextSeq Systems
NeoPrep System
VeriSeq NIPT
NovaSeq 6000
RFID Reader

Facility Registration

California Device Manufacturing License

CLIA and CAP Certifications

San Diego Clinical Service Lab
Redwood City Clinical Service Lab

ROHS Compliance

Recycling and Sustainability