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Bio-Rad Receives FDA Clearance for Blood Typing Instrument

NEW YORK (360Dx) — Bio-Rad Laboratories said on Monday that it has received 510(k) clearance for its IH-Reader 24 blood typing instrument from the US Food and Drug Administration.

According to Bio-Rad, the instrument is a centrifuge/reader combination that automatically reads and transfers blood type and antibody screening results to the company's IH-Com patient data management software. It is designed for use by medium- to small-volume laboratories.

"We … look forward to extending our reach in the US transfusion medicine market," John Hertia, president of Bio-Rad's clinical diagnostics group, said in a statement. "The system expands our offering in blood testing, allowing labs to choose the combination of Bio-Rad instruments and methods that best suit their budget and their workflow."

Bio-Rad has been steadily growing its blood typing business as of late, having received FDA clearance for the IH-Incubator L and IH-Centrifuge L — low-throughput instruments used with the firm's range of IH-System Gel manual blood typing reagents — earlier this year. The Hercules, California-based firm's high-throughput IH-1000 automated blood typing platform has been available since 2016.

The company anticipates starting US clinical testing of its IH-500 automated blood typing instrument — geared for medium-volume testing — in 2019.