FRANKLIN LAKES, N.J.,
July 19, 2017 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced that it has received
510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the BD FACSLyric™ flow cytometer
system, an easy-to-use in vitro diagnostic (IVD) system, for use
with BD Multitest™ assays for immunological assessment of
individuals and patients having or suspected of having immune
deficiency.
The BD FACSLyric system strengthens BD's portfolio of clinical
flow cytometry solutions available in the U.S. The system was CE
marked to the EU IVD Directive last year.
The new flow cytometer system combines a benchtop-sized
instrument with software, reagents and services to provide
clinicians and scientists with accurate, reliable and repeatable
results.
"The FDA clearance of the BD FACSLyric system continues BD's
drive to increase access to new innovations in clinical flow
cytometry technology to more labs around the world," said
John Ledek, president of Biosciences
for BD. "BD recognizes that products for the clinical market
require ease of use and standardization from instrument to
instrument to ensure consistent results that ultimately inform
patient care."
BD FACSLyric supports the BD Multitest™ 4-Color assays and the
BD Multitest™ 6-Color TBNK assay, which are some of the most
used flow-based IVD assays. These tests determine the percentages
and absolute counts of T, B and natural killer (NK) cells, as well
as the CD4 and CD8 subsets of T cells. Together, these metrics can
be used in the immunological assessment of individuals and patients
having, or suspected of having, immune deficiency. The BD FACSLyric
cell analyzer is available in four configurations to provide
laboratories with the flexibility to adapt to changing clinical
needs. More IVD assays will be added to the BD FACSLyric solution
as they become available.
The BD FACSLyric system is available as an IVD instrument in the
U.S., Europe and other
geographies. For more information, visit bdbiosciences.com.
About BD
BD is a global medical technology company
that is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. BD leads in
patient and health care worker safety and the technologies that
enable medical research and clinical laboratories. The company
provides innovative solutions that help advance medical research
and genomics, enhance the diagnosis of infectious disease and
cancer, improve medication management, promote infection
prevention, equip surgical and interventional procedures, and
support the management of diabetes. The company partners with
organizations around the world to address some of the most
challenging global health issues. BD has nearly 50,000 associates
across 50 countries who work in close collaboration with customers
and partners to help enhance outcomes, lower health care delivery
costs, increase efficiencies, improve health care safety and expand
access to health. For more information on BD, please visit
bd.com.
Contacts:
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Gwen
Gordon
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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858.812.3724
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201.847.5378
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gwen.gordon@bd.com
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monique_dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)