Beckman Coulter’s Chemistry-Immunoassay Workstation Cleared by FDA
Beckman Coulter, Inc. announced today that the UniCel DxC 600i Synchron Access clinical system - its newest chemistry-immunoassay workstation - has been cleared by the U.S. Food and Drug Administration. This system, to be available by mid-2006, lets clinical laboratories perform both chemistry and immunoassay testing simultaneously from a single point of sample entry. The idea is to offer flexiblity to lower-volume labs so they can consolidate workstations.
The UniCel DxC 600i aims to increase lab productivity by eliminating de-capping and re-capping steps with its closed-tube sampling (CTS) and closed-tube aliquotting (CTA) capabilities. An additional benefit is to reduce operators’ exposure to repetitive motion injuries and increase their safety. CSA International issued this certificate of compliance (pdf) for the device on January 19th, 2006.
March 6, 2006 Related topics: Product Approval & Certification, Laboratory Equipment, Diagnostic