Certificate
ISO 13485 Certification
PentaBase A/S is proud to hold ISO 13485:2016 certification (Certificate No. MD 772901), confirming our ability to design, develop, manufacture, and distribute high-quality PCR-based in vitro diagnostic assays for infectious diseases and cancer, as well as to produce oligonucleotide primers for diagnostic use. This internationally recognized standard ensures that every step of our process, from concept to global delivery, meets strict requirements for quality, safety, and regulatory compliance. Our certification demonstrates our commitment to delivering reliable, accurate, and consistent products that healthcare professionals can trust to support better diagnostics and improved patient outcomes.
Last updated: August 2025