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
Nr. of Employees
medium (51-250)
Fortress Diagnostics
Antrim, Antrim, United Kingdom, Europe
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.
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.
Services
OEM / Contract Manufacturing
Contract manufacturing and OEM services for diagnostic reagents and related products, delivered under documented service agreements and supporting literature.
Technical Support and Training
Provision of technical support, product documentation, training and distributor enablement to assist customers with product implementation and use.
IQC & EQA Programmes
Supply of internal quality control materials, calibrators and support for external quality assessment programmes for laboratory quality assurance.
Distribution Partnership and Sales Support
Establishment and management of distributor relationships, including marketing collateral, joint customer visits and commercial support for international markets.
OEM / Contract Manufacturing
Contract manufacturing and OEM services for diagnostic reagents and related products, delivered under documented service agreements and supporting literature.
Technical Support and Training
Provision of technical support, product documentation, training and distributor enablement to assist customers with product implementation and use.
IQC & EQA Programmes
Supply of internal quality control materials, calibrators and support for external quality assessment programmes for laboratory quality assurance.
Distribution Partnership and Sales Support
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)
Key Technologies
- Enzyme-linked immunosorbent assay (ELISA)
- Chemiluminescent immunoassay (CLIA)
- Molecular diagnostics (general nucleic-acid-based methods)
- Rapid diagnostic test formats