GenoScreen is ISO 13485 certified for the "design, development, manufacture, commercialization and distribution of in-vitro diagnostic kits".
This certification, delivered following a Bureau Veritas certification audit, attests to our compliance with the requirements of the ISO13485 standard and completes our ISO9001 recognition. It demonstrates that GenoScreen's commitment is part of a long-term process of constant improvement in customer satisfaction, in accordance with applicable regulatory requirements.
The ISO 13485 certification entitles GenoScreen to an official recognition in the field of diagnostic kit production. This includes specifically the Deeplex® Myc-TB kit for species-level identification and prediction of antibiotic resistance in Mycobacterium tuberculosis complex strains.