Microalbumin IVD, calibrator

This category includes materials used to set reference points for laboratory tests that measure microalbumin levels in patient samples. These calibrators are essential for ensuring the accuracy and reliability of assays designed to detect small amounts of albumin in urine, which can indicate early kidney damage.

Such devices are typically classified as in vitro diagnostic (IVD) reagents and are used to calibrate analytical instruments. They are supplied as sterile or non-sterile preparations intended for single use in diagnostic testing and are regulated based on their intended use and risk profile under applicable IVD regulations.