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Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing

September 13, 2010 By Bio-Medicine.Org

INDIANAPOLIS, Sept. 13 /PRNewswire-FirstCall/ — Roche
Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today it has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the cobas® 8000 modular
analyzer series, a Serum Work Area solution designed for diagnostic
laboratories with a workload of 3-15 million clinical
chemistry / immunochemistry tests per year.

(Photo:  http://www.newscom.com/cgi-bin/prnh/20100913/AQ63309
)

(Photo:  http://photos.prnewswire.com/prnh/20100913/AQ63309
)

The cobas 8000 series is the newest member of the Roche
cobas modular platform family, which combines clinical
chemistry and immunochemistry testing. With a peak throughput of up
to 9,800 tests per hour and up to 280 reagents onboard, it offers a
variety of features to help high-volume labs deliver reliable test
results with greater efficiency and throughput. The system also
provides extensive modular flexibility so labs can configure
tailored solutions to meet their individual needs.

With the introduction of the cobas 8000 modular analyzer
series, Roche now offers a comprehensive portfolio of standardized
integrated systems to meet the needs of all types and sizes of
clinical laboratories: the stand-alone cobas 4000 analyzer
series for low-volume labs; the cobas 6000 analyzer series
for mid-volume labs; and the cobas 8000 modular analyzer
series for high-volume labs.

“The cobas 8000 modular analyzer series delivers a new
dimension in productivity, process innovation and consolidation for
high-volume laboratories,” said Jack Phillips, president and CEO of
Roche Diagnostics Corporation. “There are many innovative design
elements that help reduce sample turnaround time, and the modular
design gives labs the freedom to

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SOURCE

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