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Bio-Rad Receives U.S. FDA Clearance for the IH-Reader 24, Expanding the Company’s Offering for the Blood Typing 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 the IH-Reader 24, a semi-automated blood typing instrument designed for medium- to small-volume laboratories.

A combination centrifuge and reader, the IH-Reader 24 automatically reads and transfers blood type and antibody screening results to Bio-Rad’s IH-Com patient data management software, offering improved efficiencies for transfusion medicine laboratories that use manual methods to test blood. The system offers standardized interpretation of results that are independent of user assessment.

With the addition of the IH-Reader 24, Bio-Rad’s portfolio of blood typing platforms offers transfusion medicine laboratories and lab networks of any size a way to standardize automated, semi-automated, and manual blood typing using products from one supplier.

“We are pleased to receive FDA clearance for the IH-Reader 24 and look forward to extending our reach in the U.S. transfusion medicine market,” said John Hertia, Bio-Rad President, Clinical Diagnostics Group. “The system expands our offering in blood testing, allowing labs to choose the combination of Bio-Rad instruments and methods that best suit their budget and their workflow.”

Bio-Rad offers a wide variety of platforms, reagents, data management, and connectivity solutions to address different blood typing needs, offering efficient and reliable results for blood grouping, phenotyping, crossmatching, antibody screening and identification, direct antiglobulin tests, and single antigen typing.

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 $2.1 billion in 2017. 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 and the opportunities that may result from such new 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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