43 devices · GMDN 53587
Urea IVD kits using enzyme spectrophotometry measure urea or blood urea nitrogen (BUN) levels in clinical samples. Clinicians rely on these tests to assess kidney function, diagnose conditions like azotemia, or distinguish between prerenal and postrenal causes of elevated urea.
These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are often sold as reagent-based systems requiring manual or automated processing, with performance validated for serum, plasma, or urine specimens.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.