Illumina Singapore Pte Ltd
Co. Reg. No.: 200310311N
29 Woodlands Industrial Park E1 Northtech Singapore 757716
Tel: 65-6579 2600 Fax: 65-6579 2601
Certificate of Conformance
Manufacturer: | Illumina, Inc. |
Name: | ASSY, INSTRUMENT, MISEQ I100 PLUS |
Material Number/ Catalog Number: | 20102513 / 20115695 |
Serial Number: | SH00894 |
Date of Manufacture: | 2025-07-07 |
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 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.
Each instrument goes through the 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 verification, which are performed by qualified and trained manufacturing personnel. The Device History Record is then approved by independent, qualified Quality Assurance personnel.
Verification Details
Verified by: | ERWIN COMETA |
Title: | Quality Operations, Illumina, Inc |
Date: | 18-Aug-2025 |
Document Information
Document number: 1000000091990 [Version 03]
Printed by: ERWIN COMETA 24-Aug-2025 0:25:23 PST
Page 1 of 1