Beckman Instruments, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 276
What Beckman Instruments, Inc. makes
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.
Catalogue
Search and filter all 276 devicesShowing 1-50 of 276
Frequently asked questions
How many devices does Beckman Instruments, Inc. have in the registry?
The registry currently lists 276 devices for Beckman Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beckman Instruments, Inc.'s devices?
Among its 50 most recently registered devices, Beckman Instruments, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Beckman Instruments, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Beckman Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beckman Instruments, Inc. in the registry?
The most recently registered devices listed for Beckman Instruments, Inc. include BECKMAN HDL CHOLESTEROL REAGENT, BECKMAN URINE PROTEIN CALIBRATOR (UCAL), BECKMAN URIC ACID REAGENT and IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT.