Tuesday, 20 August 2019

CFDA approves lab automation solution by Beckman Coulter

03 May 2019 | News

Beckman Coulter has received purchase orders for more than 20 DxA 5000 systems across multiple countries where regulatory clearance has been achieved.

Beckman Coulter, a global leader in clinical diagnostics, has announced that the latest addition to its market-leading automation portfolio, the DxA 5000 total laboratory automation solution has achieved European CE Mark and China Food and Drug Administration (CFDA) approval.

In today's healthcare environment, laboratories are highly focused on enhancing patient care by driving faster turnaround time, delivering quality results and improving laboratory operations. The DxA 5000 helps laboratories meet these challenges through a collection of patented innovations that deliver rapid and consistent turnaround time, provide a new level of comprehensive pre-analytical sample quality detection, and reduce the number of manual processing steps to significantly improve laboratory efficiency.

Reporting results faster to physicians can positively impact patient outcomes. In the laboratory, specimen centrifugation is typically the most time-consuming pre-analytical activity. The DxA 5000 sets a new standard by utilizing a universal centrifugation protocol that significantly reduces the pre-analytical processing time by up to 73% for connected analyzers across multiple disciplines.

Beckman Coulter has received purchase orders for more than 20 DxA 5000 systems across multiple countries where regulatory clearance has been achieved. A 510(k) submission for the DxA 5000 is pending clearance with the U.S. Food and Drug Administration and is not yet available in the United States.

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