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Bio-Rad Receives U.S. FDA Clearance for the IH-500, Expanding Its Offering for the Blood Testing Market


Bio-Rad Laboratories, Inc. (NYSE:BIO and BIOb), 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.

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.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE:BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our 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, California, and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.2 billion in 2018. For more information, please visit www.bio-rad.com.

This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding plans to introduce new products, the opportunities that may result from such new products and our expectations regarding our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "offers," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

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