Abbott Announces FDA Clearance of Cell-Dyn Ruby(TM) Hematology Instrument
19 Juli 2006 - 9:00PM
PR Newswire (US)
- Automated, Mid-volume Analyzer in CELL-DYN(R) Family Brings
Flexibility, Convenience to Hematology Laboratories - ABBOTT PARK,
Ill., July 19 /PRNewswire-FirstCall/ -- Today Abbott announced it
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its automated, mid-volume hematology
instrument, CELL-DYN Ruby(TM). With its advanced laser optics, this
instrument offers enhanced cellular analysis and greater efficiency
for laboratories performing complete blood counts (CBCs), a test
routinely ordered by doctors to assess a patient's overall health
and to screen for a variety of disorders such as anemia and
infection. A key facet of CELL-DYN Ruby is its use of laser light
to differentiate cellular components. Known as Multi-Angle
Polarized Scatter Separation (MAPSS(TM)), this all-optical
technology provides detailed results in easy-to-view diagrams,
visually depicting changes in white blood cells, red blood cells
and platelets. CELL-DYN Ruby also underwent a multi-center medical
evaluation showing clinically equivalent results with CELL-DYN
Sapphire(TM), a higher-volume, automated analyzer introduced about
this time last year. To streamline inventory and simplify
laboratory operations, CELL-DYN Ruby only requires four reagents.
Additionally, the instrument utilizes advanced yet intuitive
software with online tutorials to help facilitate training. "First
pass efficiency has been a hallmark of the CELL-DYN family of
analyzers and an important part of improving patient care by
providing hematology results quickly," said Harold Flynn,
divisional vice president and general manager, hematology, Abbott.
"CELL-DYN Ruby further enhances our instrument portfolio by
bringing a premium, mid-volume analyzer to support the needs of
small to medium-sized hospital laboratories and clinics." Abbott's
full line of automated hematology instruments includes the CELL-DYN
Sapphire, CELL-DYN Ruby, CELL-DYN(R) 3700, CELL-DYN(R) 3200,
CELL-DYN(R) 1800 and CELL-DYN(R) SMS(TM) [Slide Maker Stainer].
About CELL-DYN Abbott's CELL-DYN family of hematology instruments
is well known for their efficiency and ability to provide fast
access to patient results. Instruments range from larger analyzers
that process a high number of patient samples to smaller
instruments designed for medium and small-volume facilities.
Besides supplying standard CBC results, some instruments have
additional features to aid in the evaluation of more complex
disease states or infections including cancer, HIV and a variety of
anemias. About Abbott Diagnostics Abbott Diagnostics is a global
leader in in vitro diagnostics and offers a broad range of
innovative instrument systems and tests for hospitals, reference
labs, blood banks, physician offices and clinics. With more than
65,000 institutional customers in more than 100 countries, Abbott's
diagnostic products offer customers automation, convenience, cost
effectiveness and flexibility. Abbott has helped transform the
practice of medical diagnosis from an art to a science through the
company's commitment to improving patient care and lowering costs.
The history of Abbott Diagnostics is filled with examples of
first-of-a-kind products and significant technological
advancements. About Abbott Abbott is a global, broad-based health
care company devoted to the discovery, development, manufacture and
marketing of pharmaceuticals and medical products, including
nutritionals, devices and diagnostics. The company employs 65,000
people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/. DATASOURCE: Abbott
CONTACT: Media: Jim Schwartz, +1-847-937-3932, or Financial
Community: John Thomas, +1-847-935-9390, both of Abbott Web site:
http://www.abbott.com/ Company News On-Call:
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