Bio-Rad Laboratories, Inc. (NYSE: BIO), a global leader of life science research and clinical diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Bio-Rad’s IH-500, an automated random access system for blood typing and screening.
The IH-500 system was designed for small- to medium-size laboratories, offering automated blood typing and screening based on gel card technology with minimal user intervention. The system can process Bio-Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing (DAT), and crossmatch, to deliver safe and accurate results.
“We are pleased to receive FDA clearance for our IH-500 and look forward to extending our reach in the U.S. transfusion medicine market,” said John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics Group. “This addition rounds out our offering, specifically benefitting mid and smaller volume laboratories using gel technology to test blood in an automated way,” he said.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.