Certified according to EN ISO 9001:2015 and EN ISO 13485:2016 + AC:2016
These norms are applied to all our operative and incorporated processes starting from the project design to the final product, from its market launch to its post-marketing surveillance.
All our in-vitro diagnostics fulfill the regulations of the European IVD directive (98/79/EC) and are CE-marked.
In addition LDN regularly participates in national and international external quality assessment schemes (EQAS). The different schemes comprise the determination of clinical samples (urine, plasma/serum) and samples related to food safety (histamine in fish).
- Analytes we report: Catecholamines in plasma and urine, Serotonin in plasma and urine, 5-HIAA in urine, Metanephrine in urine, Normetanephrine in urine, Androstenedione in serum/plasma, 17-OH Progesterone in serum/plasma
- Analyte we report: Chromogranin A in serum
- Analyte we report: Histamine in different kinds of fish-derived matrices