Beckman Instruments, Inc.

Beckman Instruments, Inc. manufactures laboratory reagents and calibration controls for clinical chemistry analyzers, including enzyme validation sets, immunoassay reagents for rheumatoid factor and immunoglobulin E (IgE), and liquid enzyme systems for biochemical assays. Their portfolio also covers specialized reagents for drug testing, such as benzodiazepines, methadone, and cannabinoids, as well as controls for monitoring assay performance. Additional products include glucose hexokinase reagents and calibration standards for automated clinical chemistry systems.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with many listed via the 510(k) pathway. These products are intended for in vitro diagnostic use in clinical laboratories and are regulated under the U.S. Food and Drug Administration’s (FDA) In Vitro Diagnostic Device (IVD) regulations. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.