ABO/Rh multiple blood grouping IVD, kit, agglutination

35 devices · GMDN 45308

ABO/Rh multiple blood grouping IVDs use agglutination tests to detect and identify red blood cell antigens for ABO and Rh blood types. These kits help ensure accurate blood typing, which is critical for safe blood transfusions, organ transplants, and prenatal care by matching donor and recipient blood compatibility.

These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 15189 or FDA 21 CFR Part 820. They are often supplied as kits containing reagents, controls, and instructions for manual or semi-automated testing in clinical or laboratory settings.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category