Quality
Control

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).

INSTAND (www.instandev.de)

  • 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

NEQAS (www.ukneqas.org.uk)

  • Analyte we report: Chromogranin A in serum

FAPAS (www.fapas.com)

  • Analyte we report: Histamine in different kinds of fish-derived matrices

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