WATERS TECHNOLOGIES CORPORATION

Waters Technologies Corporation specializes in in vitro diagnostic (IVD) devices primarily used in laboratory settings. Their portfolio includes high-performance liquid chromatography analyser columns, mass spectrometry analysers, and therapeutic drug monitoring tools such as calibrators and controls. These devices are designed to measure immunosuppressant levels, like tacrolimus, and assist in monitoring drug concentrations in patient samples. Examples of their products include the Acquity and Xevo series, which are used for advanced chromatographic and mass spectrometry applications.

Waters Technologies Corporation is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on the risk associated with the device. This classification determines the regulatory pathway and oversight requirements, ensuring compliance with U.S. regulatory standards.

Waters Technologies Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling traceability, transparency, and compliance with U.S. regulatory requirements. This listing helps ensure that healthcare providers and regulators can easily identify and verify the devices in use.

Waters Technologies Corporation’s devices are classified under the FDA’s classification system as either Class I or Class II. Class I devices generally pose minimal risk and typically require general controls for regulation, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential risks, and benefits to patients.

The primary purpose of Waters Technologies Corporation’s devices is to support laboratory diagnostics, particularly in therapeutic drug monitoring and biochemical analysis. Their high-performance liquid chromatography analysers, mass spectrometry analysers, and related controls/calibrators are designed to measure and monitor immunosuppressant drug levels, such as tacrolimus, in patient samples. This helps clinicians optimize treatment regimens by ensuring accurate drug concentration data, which is critical for patient safety and effective disease management.