Beckman-Diagnostic Systems Group
Country not established
- Devices
- 11
What Beckman-Diagnostic Systems Group makes
The company manufactures diagnostic reagents and controls for clinical chemistry analyzers, including bilirubin, pancreatic amylase, lactate, cholesterol, and drug screening reagents for detecting substances like phenyclidine, amphetamines, and opiates. It also produces immunofixation electrophoresis controls for protein analysis and chemistry controls for instrument calibration, such as the VIGIL PRX and CX ammonia/alcohol controls.
These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I, Class II, and unclassified (U). The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Beckman-Diagnostic Systems Group have in the registry?
The registry currently lists 11 devices for Beckman-Diagnostic Systems Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beckman-Diagnostic Systems Group's devices?
Among its 11 most recently registered devices, Beckman-Diagnostic Systems Group has devices listed in FDA 510(k) (11 devices).
What risk classes do Beckman-Diagnostic Systems Group's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Beckman-Diagnostic Systems Group's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beckman-Diagnostic Systems Group in the registry?
The most recently registered devices listed for Beckman-Diagnostic Systems Group include BECKMAN DIRECT BILIRUBIN REAGENT, VIGIL PRX CHEMISTRY CONTROL, CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM and SYNCHRON CX3 DELTA.