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
• Environmental Management System
• Occupational Health and Safety Management System
• Product Documentation
• Facility Registration
• California Device Manufacturing License
• CLIA and CAP Certification
• ROHS Compliance
• Recycling and Sustainability

Quality Management Systems

United States

• ISO 13485:2016 Multisite Quality Management Certificate (San Diego, CA; Hayward, CA; Foster City, CA, Madison, WI; & Cambridge, UK)
• MDSAP: ISO 13485:2016 Quality Management Certificate (San Diego, CA & Hayward, CA)

Netherlands

• ISO 13485:2016 MD 582571 Quality Management Certificate (UKAS)
• ISO 13485:2016 MD 709921 Quality Management Certificate (RvA, Mirror)

Singapore

• ISO 13485:2016 Quality Management Certificate
• MDSAP: ISO 13485:2016 Quality Management Certificate

Environmental Management System

Singapore

• ISO 14001:2015 Environmental Management Certificate

Occupational Health and Safety Management System

Singapore

• ISO 45001:2015 Occupational Health & Safety Management Certificate

Product Documentation

NovaSeq X Series

• NovaSeq X Series (CE) Declaration of Conformity
• NovaSeq X Series UK Declaration of Conformity
• NovaSeq X Series US Canada Safety Certificate
• NovaSeq X Series CB Scheme Safety Certificate

cBot Systems

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate

HiSeq Systems

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate

Illumina DNA Prep with Enrichment Dx

• Illumina DNA Prep with Enrichment Dx Declaration of Conformity
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Bulgarian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Croatian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Czech
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Danish
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Dutch
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Estonian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Finnish
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into French
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into German
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Greek
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Hungarian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Italian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Latvian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Lithuanian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Norwegian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Polish
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Portuguese
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Romanian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Serbian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Slovak
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Slovenian
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Spanish
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Swedish
• Illumina DNA Prep with Enrichment Dx Declaration of Conformity Translated into Turkish

Infinium RoMA

• Infinium RoMA CA Declaration of Conformity
• Infinium RoMA RoHS Certificate of Conformity
• Infinium RoMA US Canada CSA Safety Certificate
• Infinium RoMA CB Scheme Safety Certificate

iScan System

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate

iSeq 100 System

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate

MiniSeq System

• MiniSeq CE Declaration of Conformity
• MiniSeq US Canada Safety Certificate
• MiniSeq CB Scheme Safety Certificate

MiSeq Systems

• MiSeq and MiSeq FGx Declaration of Conformity
• MiSeq and MiSeq FGx US Canada Safety Certificate
• MiSeqDx US Canada Safety Certificate
  
• MiSeq and MiSeq FGx CB Scheme Safety Certificate
• MiSeqDx CB Scheme Safety Certificate
• MiSeq Series CB Scheme EMC Certificate
• MiSeqDx IVD CB Scheme EMC Certificate
• MiSeqDx Reagent Kit v3 Declaration of Conformity
• MiSeqDx Cystic Fibrosis Declaration of Conformity
• TSCA Dx Kit Declaration of Conformity
• TSCA Dx - FFPE QC Delcaration of Conformity
• TruSight Cystic Fibrosis Library Prep Declaration of Conformity
• TruSight HLA Assign Declaration of Conformity
• MiSeqDx IVDR (EU) Declaration of Conformity
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Bulgarian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Croatian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Czech
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Danish
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Dutch
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Finnish
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into French
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into German
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Hungarian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Italian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Latvian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Lithuanian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Norwegian
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Polish
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Portuguese
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Spanish
• MiSeqDx IVDR (EU) Declaration of Conformity Translated into Swedish

NextSeq Systems

• NextSeq 500 550 Declaration of Conformity
• NextSeq 500 550 US Canada Safety Certificate
• NextSeq 500 550 CB Scheme Safety Certificate
• NextSeq 550Dx Declaration of Conformity
• NextSeq 550Dx US Canada Scheme Safety Certificate
• NextSeq 550Dx CB Scheme Safety Certificate
• NextSeq 550Dx High Output Reagents Declaration of Conformity
• NextSeq 1000 2000 US and Canada Safety Certificate
• NextSeq 1000 2000 CB Scheme Safety Certificate
• NextSeq 1000 2000 Declaration of Conformity
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Arabic
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Brazilian Portuguese
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Bulgarian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Croatian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Czech
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Danish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Dutch
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Estonian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Finnish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into French (Canada)
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into French (France)
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into German
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Greek
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Hebrew
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Hungarian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Italian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Latvian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Lithuanian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Norwegian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Polish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Portuguese
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Romanian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Serbian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Slovak
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Spanish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Swedish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Turkish
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Ukrainian
• NextSeq 550Dx Sequencing System IVDR (EU) Declaration of Conformity Translated into Vietnamese

NeoPrep System

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate

TruSight Oncology

• Declaration of Conformity TruSight Oncology Comprehensive (EU) TP Claim
• Declaration of Conformity TruSight Oncology Controls

VeriSeq NIPT

• Declaration of Conformity VeriSeq NIPT Solution
• Declaration of Conformity VeriSeq NIPT Analysis Software (48 Samples)
• Declaration of Conformity VeriSeq NIPT Analysis Software (16 Samples)
• VeriSeq NIPT Workflow Manager v2 IVDR (EU) Declaration of Conformity
• VeriSeq NIPT Local Run Manager IVDR (EU) Declaration of Conformity
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Bulgarian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Croatian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Czech
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Danish
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Dutch
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Finnish
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into French
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into German
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Greek
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Hungarian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Italian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Lithuanian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Norwegian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Polish
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Portuguese
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Romanian
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Spanish
• VeriSeq NIPT Solution v2 IVDR (EU) Declaration of Conformity Translated into Swedish

NovaSeq 6000

• Declaration of Conformity
• US Canada Safety Certificate
• CB Scheme Safety Certificate
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Estonian
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Czech
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Danish
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Dutch
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into German
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Finnish
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into French
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Italian
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Norwegian
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Polish
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Portuguese
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Serbian
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Slovak
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Spanish
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Swedish
• NovaSeq 6000Dx IVDR (EU) Declaration of Conformity Translated into Turkish

RFID Reader

• Declaration of Conformity

Facility Registration

• San Diego, CA (Headquarters)
• San Diego, CA (Carroll Park)
• Hayward, CA
• Singapore

California Device Manufacturing License

• San Diego, CA (Headquarters)
• San Diego, CA (Carroll Park)
• Hayward, CA

CLIA and CAP Certifications

San Diego Clinical Service Lab

• CLIA Certificate of Accreditation
• CAP Certificate of Accreditation
• California State Clinical Laboratory License
• Florida State Clinical Laboratory License
• Maryland State Medical Laboratory Permit
• Pennsylvania State Medical Laboratory Permit
• Rhode Island State Clinical Laboratory License

Redwood City Clinical Service Lab

• CLIA Certificate of Accreditation
• CAP Certificate of Accreditation
• California State Clinical Laboratory License
• Florida State Clinical Laboratory License
• New York State Medical Laboratory Permit
• Maryland State Medical Laboratory Permit
• Pennsylvania State Clinical Laboratory Permit
• Rhode Island State Clinical Laboratory License

ROHS Compliance

• MiSeqDx RoHS Declaration
• MiSeqFGx RoHS Declaration
• MiniSeq RoHS Declaration
• NextSeq 550Dx RoHS Declaration
• iSeq RoHS Declaration
• Infinium RoMA RoHS Declaration

Recycling and Sustainability

• Europe