Diamond Logo
Diamond Logo
Diamond Quality BannerQuality

Diamond prides itself on developing and consistently manufacturing products in conformance to the highest quality standards while meeting customer needs. We strive to meet and beat your quality expectations and will continue to improve the quality and value of our final product.

Diamond has been registered with the United States Food and Drug Administration since 2001 and regulated by its cGMP system requirements. Since 2006, Diamond has been certified to both ISO 9001:2015 and ISO 13485:2016 standards and has successfully maintained since. All products manufactured by Diamond carry the necessary FDA clearance and comply to the European Union IVD Directive. Every department and function in our company is standardized, controlled and routinely audited.

Diamond’s quality guarantees that the highest quality is ingrained in even the smallest daily business interaction.

FDA Registrations

Diamond Diagnostics Inc. is registered with the United States Food and Drug Administration as an Initial Importer, Manufacturer and Contract Manufacturer. Establishment registration and device listing can be found under ID: 3003030793.

Diamond has been registered with the Food and Drug Administration since 2001 and regulated by its cGMP system requirements.

All products manufactured by Diamond carry the necessary FDA clearance and comply to the European Union IVD Directive. Every department and function in our company is standardized, controlled and routinely audited.

ISO
ISO
Facebook
Instagram
Contact Us

Corporate Headquarters (USA)
Diamond Diagnostics Inc.
333 Fiske Street
Holliston, MA 01746-2048
Tel: +1 508.429.0450

Distribution Center (EU)
Diamond Diagnostics Kft.
1044 Budapest, Hungary
Óradna Street 6
Tel: +36 (1) 787 2222

Quality

ISO 9001:2015 (US)
ISO 9001:2015 (EU)
ISO 13485:2016 (US)
ISO 13485:2016 (EU)

Diamond Diagnostics Inc. is registered with the United States Food and Drug Administration as an Initial Importer Manufacturer and Contract Manufacturer. Establishment registration and device listing can be found under ID: 3003030793.

Diamond has been registered with the Food and Drug Administration since 2001 and regulated by its cGMP system requirements.

All products manufactured by Diamond carry the necessary FDA clearance and comply to the European Union IVD Directive. Every department and function in our company is standardized, controlled and routinely audited.

FDA logo

The names and logos of manufacturers, their instruments, and their products referred to herein may be protected by trademark or other law, and are used herein solely for purpose of reference. Products are available for international distribution only unless otherwise indicated. Diamond Diagnostics expressly disclaims any affiliation with products it does not manufacture, as well as sponsorship by other manufacturers. For current regulatory status on products within this website, please contact your sales representative. Prices and Information shown are for reference only and may change without notice. SmartLyte®, ProLyte®, CareLyte®, and Down-To-Frame® Refurbishing are Registered Trademarks of Diamond Diagnostics®.

©2021 Diamond Diagnostics®All Rights Reserved.