Quality – For us at Dynex Technologies, quality isn’t just a certificate on the wall; it is at the heart of everything we do. We ‘design in’ quality from initial product concept, through manufacture, delivery, and installation at the customer site. We know that customers count on our products as critical enabling tools for their important work. And our goal is to meet and exceed their expectations with the best, most cost-effective products and services available, delivered on time, and as promised.

Dynex is regulated by the United States Food and Drug Administration (FDA): all our instruments are listed and categorized as 'Class I, 510(k) exempt' In Vitro Diagnostic Devices (or IVDs.) These are considered Medical Devices according to section 210(h) of the Federal Food, Drug, and Cosmetic Act. Dynex therefore adheres to US FDA 21CFR820 and is subject to periodic inspections by the FDA.

Dynex instruments used in conjunction with third-party diagnostic kits may require validation studies to assure proper assay performance, and this pairing may change the overall classification of the system depending on the resulting risk assessment.

Dynex is an FDA registered company and is ISO 13485:2003 certified. To view online copies of Instrument or Company certifications, click here. For more information about our quality policies, click here.