Bio-Rad Gains Additional U.S. FDA Clearances for Blood Typing Products, Expanding its Offering for the Blood Testing Market
January 22 2018 - 4:15PM
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 the IH-Incubator L and
IH-Centrifuge L instruments to be used with the full range
of Bio-Rad’s IH-System Gel Reagents for manual blood typing
methods.
With the addition of the IH-Centrifuge L and
IH-Incubator L to Bio-Rad’s portfolio of blood typing
platforms, transfusion medicine laboratories of any size can
standardize automated and manual typing with one method and
supplier. The unique design of the two instruments maximizes
efficiency and space in the laboratory by accommodating both
conventional tube and gel blood typing.
“We are pleased to receive FDA clearance for our
IH-Incubator L and IH-Centrifuge L instruments for
use with our IH-System Gel Reagents 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 smaller laboratories that use manual
methods to test blood.”
Bio-Rad provides 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 and solutions 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
research laboratories that include food safety and environmental
quality testing. 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
billion in 2016. For more information, please visit
www.bio-rad.com.
Bio-Rad Forward-Looking Statements
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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version on businesswire.com: http://www.businesswire.com/news/home/20180122006450/en/
Bio-Rad Laboratories, Inc.Tina Cuccia, 510-724-7000Corporate
Communicationstina_cuccia@bio-rad.com
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