Real-time PCR-based genetic test for detection of the deltaF508 mutation associated with cystic fibrosis. Enables rapid molecular diagnosis through cutting-edge genetic analysis technology. ISO 13485:2016 certified IVD product compliant with EU Regulation 2017/746.
Manufactured by
Zaragoza, Spain
As a biotechnology company, BDR is focused on researching, developing, producing and selling in vitro diagnostic products for human diagnostics (CE-IVD). BDR is specialized in Real Time PCR (qPCR), fragment analysis (QF-PCR) and NGS technologies, apart from having its own bioinformatics department in charge of the development of specific software for the analysis of results. Our quality system complies with the most demanding international standards. We have all the required certifications for European manufacturers (UNE-EN-ISO 13485, CE certification, compliance with the European Directive 98/79/CE). In addition, our continuous improvement program includes the yearly participation in External Quality Assessments (EQAs) through different international entities, always obtaining a high score.
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