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Bio-Rad Gets 510(k) for Blood Typing Instrument Software Enhancements

NEW YORK (360Dx) – Bio-Rad Laboratories has received 510(k) clearance from the US Food and Drug Administration for enhancements to its IH-Com patient results management software for the IH-1000 automated blood typing platform, which has been commercially available in the US since 2016.

The data management tool combines current and prior patient results to deliver an overall interpretation and crosscheck. It can link instruments within and across labs and facilitates data transfer to lab information systems (LIS).

The new clearance now provides more options to automate the release of test results LIS.

"Expanded options can lead to a more rapid and efficient delivery of safe and accurate patient results, significant workflow improvements, and overall a more lean laboratory operation," John Hertia, Bio-Rad's executive vice-president and president of its clinical diagnostics group, said in a statement.