Manufacturer Information
Manufacturer: Illumina, Inc.
Name: RFB, Assy, NextSeq 550 Sequencing System
Material Number / Catalog Number: 15067451R / SY-415-1002
Serial Number: NB552866R
Date of Manufacture: 2022-02-17
Certification Details
This document certifies that each instrument conforms to Illumina specifications and is developed and validated following a certified Quality System, which conforms to ISO 13485 requirements. The integrity of the Illumina Quality System is routinely audited and is certified by the British Standards Institute (BSI, Inc.), a quality management system registrar, as meeting the requirements of ISO 13485.
Instrument Testing and Verification
Each instrument goes through Final Instrument Test with defined acceptance criteria. In accordance with the Device History Record, each instrument must pass the Final Instrument Test and cosmetic and labeling verifications, which are performed by qualified and trained manufacturing personnel. The Device History Record is then approved by independent, qualified Quality Assurance personnel.
Name: Thangaraju Sivakumar
Authorized Signature: [Signature Placeholder]
Title: Quality Technician
Date: 22 Aug 2025
Document No: 1000000091990 v03, Effective Date: 31-Jul-2024
