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Overview

Developing diagnostic solutions for diseases that are of public health importance globally

Labsystems Diagnostics is based in Finland and has been a forerunner in innovative diagnostic research and development for nearly 40 years, pioneering new technologies for newborn screening and point of care testing. Among the market leaders in newborn screening, our neonatal products save and improve the lives of babies in more than 70 countries. Being a one-stop solution provider for newborn screening, offering the most comprehensive and high quality screening kits, supported by best-in-class automation capabilities and user friendly software, we have a strong record of technology leadership, including pioneering research to enable the early detection of diseases.

Quality Statement

Labsystems Diagnostics develops, manufactures and markets high-quality and safe diagnostic products, which are based on defined quality specifications and fulfil relevant regulatory requirements. The strengths of Labsystems Diagnostics are know-how and continuous product development, which we use to respond to clinical needs.

Our quality target is to deliver products fulfilling our quality criteria in agreed time and ensure at all times the patient safetyand the customer satisfaction. To achieve our goals in quality, the whole personnel is conscious about the importance of the high quality.

Labsystems Diagnostics was the first to:

  • Develop fluorometric PKU [Phenylketonuria] tests for NBS
  • Provide PKU assays in micro-plate format

We continue to invest in our R&D and are strongly committed to developing innovative newborn diagnostics solutions at our state of the art production facility in Vantaa, Finland.

Besides newborn screening, our core competencies and capabilities include point of care testing, molecular testing, immunoassay development, automated manufacturing and mass spectrometry solutions. With a thriving commercial organization around the world, Labsystems Diagnostics remains steadfast in serving its customers through high quality products and solutions that met the required regulatory and safety standards.

Certifications

Labsystems Diagnostics Oy design, development, manufacturing, marketing and sales of reagents and reagent products are in line with several regulations. Equipped with automated robotics assembly and production lines, Labsystems delivers quality in accordance with ISO 13485 and IVDD CE guidelines.