Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Bio-Rad Blood Typing Products

NEW YORK (360Dx) – Bio-Rad Laboratories announced after the close of the market on Monday that the US Food and Drug Administration cleared two of its instruments for blood typing.

The agency provided 510(k) clearance for Bio-Rad's IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents for manual blood typing. The addition of the two products to its blood typing platforms allows transfusion medicine labs of any size to standardize automated and manual typing with one method and supplier, Bio-Rad said.

"This addition rounds out our offering, specifically benefitting smaller laboratories that use manual methods to test blood," said John Hertia, Bio-Rad executive vice president and president of the Clinical Diagnostics Group, in a statement.