Histology & Microscopy

Reagents for Clinical Diagnostics (IVDR)

Our Clinical Diagnostics product line is manufactured under strict IVDR‑compliant processes, guaranteeing the highest level of safety, traceability, and regulatory assurance for in vitro diagnostic applications. These products are designed for use in clinical laboratories, hospitals, and diagnostic platforms where performance, consistency, and compliance with European Regulation (EU) 2017/746 are essential.

In a hospital’s anatomic pathology laboratory, tissue samples follow a standardized preparation workflow to support accurate and consistent diagnosis. After fixation, samples undergo gross examination, followed by tissue processing, where they are dehydrated, cleared, and infiltrated with paraffin. They are then embedded into paraffin blocks, sectioned into thin slices, and stained—most commonly with hematoxylin and eosin (H&E), along with special stains when required. Finally, slides are mounted before microscopic evaluation by the pathologist.

At every step of this workflow, the use of high‑quality, IVDR‑compliant reagents is essential to ensure reliable, reproducible, and diagnostically robust results.

Each of our reagents is produced with validated methods, robust documentation, controlled manufacturing environments, and complete batch traceability. Stability, accuracy, and reproducibility are rigorously verified to ensure reliable diagnostic performance in every test.

With ITW Reagents, laboratories can trust products that meet the demanding standards of IVDR—supporting confident clinical decisions and secure patient outcomes.