NEW YORK (360Dx) – Beckman Coulter said today that its DxA 5000 system total laboratory automation solution has received CE marking and approval from the Chinese National Medical Products Administration, formerly called the Chinese FDA.
The DxA 5000 is a clinical lab automation solution that reduces the number of required manual steps. According to the company, which is part of Danaher, the system uses a universal centrifugation protocol that reduces the preanalytical processing time by up to 73 percent for connected analyzers across multiple disciplines.
Beckman Coulter said that it has received purchase orders for more than 20 of the systems in multiple countries where it has received regulatory clearance. The DxA 5000 is currently awaiting potential 510(k) clearance from the US Food and Drug Administration.