Proprietary data management software designed for transplant laboratories to organize, analyze, and report genetic diagnostic results. Integrates real-time PCR and fragment analysis data for HLA typing and rare disease diagnosis. Supports ISO 13485 and EU IVD Regulation 2017/746 compliance for clini...
Manufactured by
Blackhills Diagnostic Resources, S.L.U. BDR
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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