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HiSS Diagnostics GmbH was founded in 1989 in Freiburg im Breisgau, Germany. Initially,we almost exclusively used to represent several products for the use in microbiology, immunology, and quality control in medical laboratories from manufacturers primarily located in the United States or the Netherlands.
Since 1999 we started manufacturing our NOVITEC® in-vitro diagnostics for medical microbiology laboratories. In addition, we still do offer "Total Quality Management" products as well as research reagents, such as antibodies for use in genetics, cell biology, immunology and/or pathology or various tool sets for preparation and purification of DNA or RNA. Since 2001 we serve the various markets in Europe and overseas.
Our in-vitro-diagnostics conform with the 98/79EC directive (IVDD= in vitro diagnostics directive) including risk analysis, data collection and manufacturing processes. Since June 1999 we registered a quality management system with the local authority, the Regierungspräsidium Freiburg (reg no.: DE/142108036), which is based on GMP (good manufacturing practice).
We have completed our certification process for DIN EN ISO 13485:2003 under CMDCAS. Certificates are available upon reguest.
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