Clinical Reagents

Reliable Components of Successful Clinical Outcomes

Insights that impact the well-being of patients should never be held back by ambiguities due to imprecise assay reagents

 

Immudex is committed to high-quality clinical reagents to support precision immune monitoring

  • Determine the safety and efficacy of therapeutic agents
  • Detect and diagnose diseases
  • Anticipate the progression of the disease
  • Support therapy management and evidence-based therapy decisions

Our Approach to Clinical Reagents​

Meet all relevant quality standards

Suitability for regulated use according to ISO 13485 and FDA GMP (21 CFR 820), as:

  • Components of in vitro diagnostic laboratory-developed tests (LDT)
  • Reagents for medical devices governed by authoritative regulatory guidelines and bodies
  • Tools for clinical investigations in compliance with good clinical (laboratory) practice, like immune monitoring
  • Materials in manufacturing and quality control of investigational and commercial pharmaceutical products according to Good Manufacturing Practices (GMP)

Long term partnering based on trust and excellence

Whatever the clinical enterprise, Immudex stands as a steadfast partner from start to finish:

  • With global reach, over 10 years of experience in manufacturing, and time-tested technologies, Immudex provides high-quality cellular immune monitoring solutions for better treatments
  • Immudex focuses on your clinical objectives, prioritizing and supporting the development of effective strategies for successful clinical outcomes

Dextramer® CMV Kit (IVD)

Quantify CMV-specific CD8+ T cells in whole blood to assess the corresponding immune status of patients

Clinical-Grade Dextramer® Reagents

Develop clinical-grade reagents as part of a strategy that meets specific clinical objectives and settings