35 devices · GMDN 56705
Fluorescent immunoassay analysers are advanced laboratory instruments designed to detect and measure specific substances—like hormones, proteins, or infectious agents—in patient samples. By using fluorescence to identify immune reactions between reagents and specimens, these devices provide precise, automated results for diagnostics, research, or clinical monitoring.
These analysers are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are often supplied as fully automated systems with integrated software for data processing, requiring specialized training for operation and maintenance in clinical or research settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.