19 devices · GMDN 53475
This category covers in vitro diagnostic kits designed to quantitatively measure microalbumin levels in clinical specimens. These devices utilize nephelometry or turbidimetry methods to detect low concentrations of albumin in urine, which is a key early indicator of kidney damage. They are used in clinical laboratories to screen for and monitor diabetic nephropathy and other renal conditions.
These devices are supplied as complete reagent kits containing all necessary components for the specified analytical method. They are intended for use by trained laboratory professionals on compatible automated analyzers. Regulatory classification and supply models vary by jurisdiction and are determined on a per-device basis.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.