FDA offers supplementary clearances to Bio-Rad’s IH-System Gel Reagents, Blood Typing Products

U.S FDA has granted 510 (k) clearance to Bio-Rad Laboratories for the IH-Incubator L and IH-Centrifuge L instruments to be used with the full range of Bio-Rad’s IH-System Gel Reagents for manual blood typing methods. With the addition of the IH-Centrifuge L and IH-Incubator L to Bio-Rad’s portfolio of blood typing platforms, transfusion medicine laboratories of any size can standardize automated and manual typing with one method and supplier. Hence, efficiency is maximized and space in the laboratory augmented by incorporating both conventional tube and gel blood typing.

John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics Group. “This addition rounds out our offering, specifically benefiting smaller laboratories that use manual methods to test blood.”