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Overview

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

Accurate diagnostic tests play a key role in patient management and the control of most dangerous diseases. A major outreach effort made by combining scientific, technological and academic expertise is needed for developing next-generation diagnostic tests.

With a similar vision, Labsystems Diagnostics Oy, a Finnish establishment develops, manufactures, markets and sells high-quality diagnostic tests globally for clinical laboratory use, home use and doctors’ offices. After the acquisition by the India-based global healthcare group Trivitron, Labsystems Diagnostics Oy raised the bars in the In Vitro Diagnostics sector.

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.

Featured Products

  • The predominant innovation from the house of Labsystems Diagnostics Oy is their complete range of Newborn Screening systems and tests. From fully integrated robotic platforms to systems based on fluorescence detection and various assays for diagnosis, Labsystems stands as the second most important manufacturer of newborn screening tests worldwide.
  • Labsystems Diagnostics is a house of repute for the infectious disease tests for more than three decades. They are the first diagnostics manufacturing facility to create EIA tests on a microplate format and EIA tests based on peptide technology. Currently, they produce well recognized high-quality EIA tests,convenient duplex real-time PCR tests and Biocard POC tests especially for respiratory infections.
  • Labsystems developed their own brand called BiocardTM, which is a trademark listed in the Master lists of the College of American Pathologists (CAP) Proficiency testing (PT). Under their BiocardTM Point-of-Care brand, they developed the first and only tests available for detecting Chlamydia pneumoniae and Mycoplasma pneumoniae. Along with this, they also manufacture Gastro and Cardiac POC tests under the same BiocardTM brand.
  • Labsystems Diagnostics marked its name as an experienced OEM producer for several home tests products such as Pregnancy tests, Ovulation tests and the patented Celiac tests.

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.