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ISO 13485: 2016

Luminex Corporation
12212 Technology Blvd.
Austin
Building A
78727
USA

Certificate Number: MD 800613
Scope: Design, development, manufacture, distribution, installation and service of microsphere-based and PCR-based systems used in the detection, diagnosis and/or management of nucleic acids related to hereditary diseases, drug metabolism and infectious diseases including software, hardware and reagents. Contract manufacturer of custom primer mixes for in vitro diagnostic use.

Original Registration Date	Effective Date	Last Revision Date	Expiry Date
2024-01-24	2024-06-22	2025-07-11	2027-06-21

Site Name	Site Address	Certificate/License number	Standard/Scheme number or name
Luminex Corporation	12212 Technology Blvd. Building A Austin USA	MD 800613	ISO 13485: 2016
Luminex Corporation	12212 Technology Blvd. Building B Austin USA	MD 800613	ISO 13485: 2016
Luminex Corporation	12201 Technology Blvd. Building C Austin USA	MD 800613	ISO 13485: 2016
Luminex Corporation	12100 Technology Blvd. Building D Austin USA	MD 800613	ISO 13485: 2016
Luminex Corporation	12306 Technology Blvd. Building G Austin USA	MD 800613	ISO 13485: 2016
Luminex Corporation	1224 Deming Way Madison USA	MD 800613	ISO 13485: 2016
Luminex Molecular Diagnostics, Inc.	439 University Avenue Toronto Canada	MD 800613	ISO 13485: 2016