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Supporting you with innovation and productivity throughout the entire clinical diagnostics product life cycle
Thermo Fisher Scientific delivers innovative, ready-to-deploy diagnostic solutions across all major clinical disciplines. Our global manufacturing footprint, deep technical expertise, and flexible service models empower you to accelerate development, strengthen operational efficiency, and help ensure quality and security of supply. Partner with a world leader in serving science to bring differentiated diagnostics to market and support improved patient outcomes worldwide.
Wide range of diagnostic disciplines
Clinical diagnostics solutions
Our integrated approach spans the full clinical diagnostics lifecycle, ensuring helping to ensure you have the support, expertise, and infrastructure needed at every stage. From early research and product design to manufacturing and commercialization, we help you accelerate innovation and confidently bring high-quality diagnostic solutions to market.
Manufacturing capabilities
Trusted partner for the clinical diagnostics industry for over 40 years
Manufacturing scale and efficiency
Global manufacturing sites
Total footprint >450,000 ft2
Flexible End-to-end diagnostic operations and capacity
Automation & high-speed fill lines
Cold & Frozen storage environment
Supplier management and secondary sourcing
Product development & commercialization
Assay development for a wide range of diagnostic disciplines.
Instrument development from benchtop IA and CC analyzers to total Lab Automation
Co-development and commercialization from concept to go-to-market and clinical demand generation
Quality and regulatory services
IVDR & MDSAP certified systems
Trusted by FDA and CE IVD authorities
Regulatory and registration support and services
Continuous improvement culture with Quality-by-Design
Global footprint
We fulfill our mission to help enable our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services and by ensuring global regulatory compliance.
Fremont, CA, US
- ISO 13485:2016
- MDSAP Certification
- APHIS Certification
- FDA Registered
- DEA License
- CA Medical Device
- IVDR Certified
- Manufacturer License
Middletown, VA, US
- ISO 13485:2016
- MDSAP Certification
- APHIS Certification
- FDA Registered
- CA Medical Device
- IVDR Certified
- Manufacturer License
Hennigsdorf and Nimés
- ISO 13485:2016
- MDSAP Certification
- APHIS Certification
- FDA Registered
- CA Medical Device
- IVDR Certified
- Manufacturer License
Suzhou, China
- ISO 13485:2016
- FDA Registered
Vantaa, Finland
- ISO 13485:2016
- MDSAP Certification
- FDA Registered
- CA Medical Device
- IVDR Certified
- Manufacturer License
Suite of services
Benefit from our capabilities and expertise to outsource, consolidate and add a second source to optimize your operations
We offer a comprehensive suite of services that span the entire diagnostics product lifecycle. Whether you require critical raw materials, specialized assay development, OEM instrumentation, third-party controls, or high-volume kit manufacturing, our teams deliver tailored solutions built on decades of experience. With IVDR and MDSAP-certified systems and trusted regulatory expertise, we help you innovate faster, streamline development, and strengthen your competitive position in the clinical diagnostics marketplace.
>500 - 40,000L tanks
>400,000L capacity
Custom container filling
Variable volume filling (1ml vials to 210L)
High-speed fill lines
Standard and custom labels
Kit packaging – hand packed or automated
Warehousing
Low to mid throughput lab automation assembly
Benchtop IA and CC analyzers assembly
End-to-end diagnostic development services and solutions to optimize your portfolio
Support to accelerate speed to market by expanding the pipeline, expediting product development and optimizing portfolio value
Discovery and development of biological materials (antibodies, antigens)
Recombinant and plasma
Proprietary assay designs
Instrument and lab automation design
Software capabilities
Custom, OEM, and application development and V&V service
Experience with open / closed immunochemistry platforms
Robust stage gate and design control process
Clinical evidence generation, study planning and execution
Compiling regulatory dossiers and filing with global authorities
HEOR strategy, evidence generation
Specialty IVD assay portfolios ready to deploy on customer platform
Third party controls, instrumentation and automation solutions
Quality Controls & standards
Third-party quality control solutions, software and standards for clinical chemistry, immunoassay, molecular and sequencing tests
Our established global infrastructure provides the scale, flexibility, and technical depth needed to support your growing diagnostic portfolio. With extensive tank capacity for liquid formulation, custom and high-speed container filling, automated and manual kit packaging, lyophilization capabilities, and dedicated lab automation and instrument assembly lines, we offer consolidated, reliable, and cost-effective outsourcing options. Whether you’re optimizing operations or adding a second source, our manufacturing network ensures quality, efficiency, and continuity of supply.
Quality controls-innovative portfolio and applications
Delivering consistent and highly characterized results through rigorous lot-to-lot quality, enhanced accuracy, faster turnaround times, and cost-effective solutions designed for today’s lean budgets
- Multi-analyte quality controls
- Molecular transplant & infectious disease
- Blood screening & oncology
- Hospital acquired infections
- Women's health
For Research Use Only. Not for use in diagnostic procedures.