22 devices · GMDN 42440
A microtome blade IVD, single-use is a thin, sharp, wedge-shaped blade designed to be mounted in a microtome for cutting extremely thin sections of paraffin-embedded tissue. These sections are then placed on slides for staining and microscopic examination, enabling histopathological analysis in clinical laboratories.
As a single-use in vitro diagnostic device, it is intended for one-time use only to prevent cross-contamination and ensure consistent cutting performance. Regulatory oversight focuses on its role in specimen preparation for diagnostic testing, with requirements centered on material safety, sterility (if applicable), and performance consistency rather than therapeutic action.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.