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ISO 13485:2003 Certified

The Company

Chematics is a privately held biotechnology company engaged in the development and manufacture of novel in-vitro diagnostic testing solutions and products that facilitate early identification of abnormal or unhealthy conditions. Founded in 1988, Chematics is located in North Webster Indiana. Our objective as a company is to provide our customers worldwide with innovative easy to use products, at a reasonable price that are of the highest quality and are safe and effective when used for the purposes for which they are intended. Our success as a business depends upon achievement of this objective and upon continuous improvement of our products, processes and customer experiences.

Quality and Regulatory Information

Chematics is committed to being a good corporate citizen and of upholding our duty to the community and to our customers. It is our policy as a company to comply with all applicable laws and regulations relating to our manufacturing and business activities. Our ISO 13485:2003 certified Quality Management System is designed and implemented to achieve a state of continuous improvement and to conform to the standards and national and international regulations governing the manufacture and distribution of our medical devices. Our Alco-Screen®, Alco-Screen® 02, Chemcard™ Cholesterol and Chemcard™ Glucose are registered with The US Food and Drug Administration (FDA). The Chemcard™ Cholesterol and Chemcard™ Glucose have received 510(k) clearance for marketing in the USA. The Alco-Screen®, Chemcard™ Cholesterol and Chemcard™ Glucose test devices are CE marked for marketing in the EU under the IVD Directive 98/79/EC.