Quality – For us at Magellan Biosciences, 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.

ESA and Dynex are regulated by the United States Food and Drug Administration (FDA): when used for clinical applications, Dynex's instruments and accessories are classified as Class 1 medical devices, and ESA's are Class 1 and Class 2 medical devices. Therefore, these products are designed and manufactured under the Medical Device Quality System Regulation, also known as Current Good Manufacturing Practices (cGMP), and are subject to periodic inspection by the FDA. ESA and Dynex adhere to US FDA 21CFR820.

See a selected list of our credentials, certifications, and accreditations below. For more information about Magellan's quality policies, click here.

ESA

ISO 9001:2000 and ISO 13485:2003 certifications

Credentials and accreditations:

• Industrial Hygiene: American Industrial Hygiene Association
• Clinical Analyses: Health Care Financing Administration, CLIA Certificate
• Blood Lead: OSHA List of Acceptable Laboratories; ESA's LeadCare product is a class 2 device

Proficiency programs:

• Blood Lead: CDC Reference Laboratory
• WSLH Proficiency Testing Program
• Hematology: WSLH Proficiency Testing Program
• Micronutrient Measurement Quality Assurance Program (M2QAP)
• Industrial Hygiene: AIHA PAT Program
• Industrial Hygiene: WASP Formaldehyde Program

Dynex

ISO 9001:2000 certification