Fortress Diagnostics


Fortress Diagnostics is a global provider of in vitro diagnostics (IVDs). They develop, manufacture, and support an extensive portfolio of clinical diagnostic tests from their ISO 13485:2016-accredited facility in the United Kingdom. They serve immunology, haematology, and serological laboratories in hospitals, medical centers, clinics, blood banks, and research institutions across over 100 international markets. The company is committed to advancing healthcare through continued investment in research and development, maintaining high-quality standards, and providing technical support and training to their distributors.

Industries

health-care
manufacturing
medical-device

Nr. of Employees

medium (51-250)

Fortress Diagnostics

The Technology Park, Belfast Road, Co. Antrim, N Ireland, BT41 1QS


Products

Immunoassay kits (ELISA)

ELISA-format immunoassay kits for clinical diagnostic use across various indications.

Immunoassay kits (chemiluminescent)

Chemiluminescent immunoassay kits for automated or semi-automated platforms.

Molecular diagnostics

Molecular diagnostic assays for nucleic-acid-based testing applications.

Clinical chemistry reagents and analyser-specific reagents

Reagents for clinical chemistry testing and analyser-specific formulations for laboratory analysers.

Haematology reagents

Reagents and consumables for haematology testing.

Coagulation and haemostasis assays

Reagents for coagulation and haemostasis testing.

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Services

Contract manufacturing and OEM services for diagnostic reagents and related products, delivered under documented service agreements and supporting literature.

Provision of technical support, product documentation, training and distributor enablement to assist customers with product implementation and use.

Supply of internal quality control materials, calibrators and support for external quality assessment programmes for laboratory quality assurance.

Establishment and management of distributor relationships, including marketing collateral, joint customer visits and commercial support for international markets.

Expertise Areas

  • In vitro diagnostic (IVD) assay development
  • IVD manufacturing and formulation
  • Quality management and ISO 13485 compliance
  • Assay portfolio management (immunoassays, molecular, chemistry, haematology, rapid tests)
  • Show More (4)

Key Technologies

  • Enzyme-linked immunosorbent assay (ELISA)
  • Chemiluminescent immunoassay (CLIA)
  • Molecular diagnostics (general nucleic-acid-based methods)
  • Rapid diagnostic test formats
  • Show More (6)

News & Updates

03 February 2020 - 06 February 2020 MEDLAB Middle East - Dubai World Trade Centre, UAE

04 February 2020 - 04 February 2020

14 June 2020 - 20 June 2020 Diabetes Global Awareness

14 November 2022 - 17 November 2022 MEDICA - Messe Düsseldorf, Germany

13 November 2023 - 16 November 2023 MEDICA - Messe Düsseldorf, Germany

05 February 2024 - 08 February 2024 Dubai World Trade Centre

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