Product Details
- Manufacturer:
- Illumina, Inc.
- Name:
- ASSY, INSTRUMENT, MISEQ I100
- Material Number/Catalog Number:
- 20130387/20115694
- Serial Number:
- SL00310
- Date of Manufacture:
- 2025-08-22
Conformance Statement
This document certifies that each instrument conforms to Illumina specifications andis developed and validated following a certified Quality System, which conformstoISO 13485 requirements. The integrity of the Illumina Quality System is routinelyaudited and is certified by the British Standards Institute (BSI, Inc.), a qualitymanagement system registrar, as meeting the requirements of ISO 13485.
Each instrument goes through Final Instrument Test with defined acceptance criteria.In accordance with the Device History Record, each instrument must pass the FinalInstrument Test and cosmetic and labeling verifications, which are performed byqualified and trained manufacturing personnel. The Device History Record is thenapproved by independent, qualified Quality Assurance personnel.
Authorization
- Name:
- Alyna Shiju
- Title:
- Quality Technician
- Authorized Signature:
- [Handwritten Signature]
- Date:
- 24 AUG 2025
