FDA Grants 510(k) Approval to Ortho Clinical Diagnostics for Ortho Vision Analyzer
The FDA has granted 510(k) approval to Ortho Clinical Diagnostics for its automated Ortho Vision analyzer.
The analyzer helps transfusion medicine professionals track critical steps in the immunohematology testing process. It features Intellicheck technology, which helps the device verify and document diagnostic checks throughout the testing process.
It also contains e-Connectivity technology, which provides continuous remote data tracking to monitor instrument performance.
Ortho Clinical Diagnostics, which is headquartered in Raritan, N.J., markets a version of the device in Europe, Japan, Latin America, Canada and Australia. — Michael Cipriano