Bio-Rad Receives FDA Clearance for the IH-500

Bio-Rad Laboratories Inc., a global leader of life science research and clinical diagnostic products, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 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.
 
Bio-Rad offers a wide variety of platforms, reagents, data management, and connectivity solutions to address different volume blood typing needs. Using Bio-Rad’s IH-Com patient data management software and IH-Web remote results management interface, the IH-500 and other Bio-Rad blood typing and screening instruments can be seamlessly integrated to help laboratories to more efficiently manage their blood testing workload.
 
Bio-Rad is a trademark of Bio-Rad Laboratories Inc. and IH-500 and IH-Com are trademarks of Bio-Rad Europe GmbH in certain jurisdictions.
 
Bio-Rad Laboratories Inc. develops, manufactures, and markets products for the life science research and clinical diagnostic markets. For over 65 years, its products have advanced the discovery process and improved healthcare. The company’s customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, Calif., and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.2 billion in 2018.