Genencor International Launches Enzyme Technology for Prion Decontamination
Prionzyme M, the first enzyme from the new line of products, carries the CE mark indicating that the protease conforms with the essential requirements established by the European Medical Device Directive 93/42/EEC. Genencor plans for its additional Prionzyme products to also carry the CE designation. Genencor also recently received the ISO 13485:2003 registration at its Cedar Rapids, Iowa production site, where the Prionzyme products are manufactured. Following an extensive audit of the site's quality systems, Lloyd's Register Quality Assurance, a International Standards Organization (ISO) registrar and European Community Notified Body, awarded the ISO 13485 certificate of registration.
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