Redondo Beach, CA – November 20, 2003 – Quantimetrix Corporation is pleased to announce that they are certified for a Quality management System according to EN ISO 13485:2000 and are compliant with the regulatory requirements of the European Union (EU) In Vitro Diagnostic Directive (IVDD) and the Canadian Medical Device Conformity Assessment (CMDCAS) through TUV Rheinland of North America.
Quantimetrix has met the requirements to CE-Mark its top 15 products, allowing for its sale into the European market.
Quantimetrix develops and manufactures innovative clinical diagnostic products for global distribution, including Lipoprint®, the only diagnostic test for the separation and measurement of cholesterol in lipoprotein fractions and subfractions. Other products include urinalysis, general and specialty chemistry controls, electrophoresis systems, diagnostic assays and OEM controls. Quantimetrix corporate headquarters is located at 2005 Manhattan Beach Blvd., Redondo Beach, CA 90278; phone: 800-624-8380. Additional information about the company and its products can be found at www.4qc.com.