Amphetamine-specific IVD, calibrator

This category includes reference materials used to set known concentration points for tests that detect a specific amphetamine in clinical samples such as blood, urine, or oral fluid. These calibrators are essential for ensuring the accuracy and reliability of qualitative or quantitative assays designed to identify amphetamines in diagnostic or monitoring settings.

Devices in this category are regulated as in vitro diagnostic (IVD) medical devices and are typically supplied as single-use or limited-use preparations. They are not tests themselves but are used to calibrate or validate the performance of amphetamine-specific IVD assays, with their regulatory status derived from the IVD they support.