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

April 8, 2019 Off By BusinessWire

HERCULES, Calif.–(BUSINESS WIRE)–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.

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