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Ortho Immunohematology System Receives China Regulatory Approval

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that the China Food and Drug Administration has granted approval of its Ortho Vision platform of fully automated blood analyzers for low-, mid-, and high-volume transfusion medicine laboratories. The platform consists of Ortho Vison and Ortho Vision Max. Following the approval, the Ortho Vision platform is now commercially available in China. 

The instruments have been commercially available in other various locations around the world, including in the US and Europe, the firm said.  

The Ortho Vision platform consists of analyzers that test blood for compatibility and ensure that transfusion patients receive the correct blood. It was developed for mid-volume labs, Ortho said, while the Ortho Vision Max platform was developed for use in mid- to high-volume labs. It supports more complex immunohematology testing, such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification, Ortho said.

Robert Yates, chief operating officer of Ortho Clinical Diagnostics, said in a statement that the approval in China reflects the firm's commitment to "helping labs become more efficient while continuing to perform precise, accurate testing."

The firm noted that the Ortho Vision platform is designed to manage unpredictable workflow, and enable the transfusion medicine department to process routine samples and stat orders as they are received, rather than waiting for a complete batch before running the instrument.