FDA Registration
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.
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®. No mobile information will be shared with third parties/affiliates for marketing/promotional purposes. All the above categories exclude text messaging originator opt-in data and consent; this information will not be shared with any third parties.