Clinical Reagents

Immudex' clinical reagents and In Vitro Diagnostic (IVD) products allow efficient and accurate antigen-specific T-cell enumeration in blood samples.

All clinical reagents are manufactured in accordance with quality system requirements for medical devices defined by ISO 13485 and 21 CFR 820, making them suitable for regulated usage, such as:

• In vitro diagnostic, including components in laboratory developed tests (LDT) or medical devices governed by Clinical Laboratory Improvement Amendments (CLIA) and Food and Drug Administration (FDA), respectively, in US, and by the In Vitro Diagnostic Directive (IVDD) in EU 
• Clinical investigations in accordance with good clinical (laboratory) practice (GC(L) P) for compliance with the ethical principles of medical research, involving human subjects set forth by the Declaration of Helsinki
• Manufacturing and quality control of investigational and commercial pharmaceutical products in compliance with good manufacturing practices (GMP).

If you need a customized strategy to perform specific immune monitoring in clinical setting, please let us know what you are looking for, and we will help support your T-cell immune monitoring.

If you are interested in assessing CMV-specific immune status in patients, please check:

• Dextramer® CMV Kit - In Vitro Diagnostics