-FDA greenlights Cellavision's body fluid analysing application.
NORDIC BUSINESS REPORT-September 27, 2011--FDA greenlights Cellavision's body fluid analysing application(C)2011 M2 COMMUNICATIONS http://www.m2.com
27 September 2011 - Swedish Cellavision AB (STO:CEVI) said today the US Food and Drug Administration (FDA) had approved its application for body fluid analysis for use on the cell morphology system Cellavision DM1200.
The application can be used to analyse various body fluids, including spinal, synovial and pleural fluid.
Following the clearance, Cellavision will be able to offer medium-size laboratories in the USA a fully automated analyser for both blood and other body fluids, Ron Hagner, vice president at Cellavision North America, said.
The Swedish company has two cell morphology systems -- Cellavision DM96 for use in big laboratories and Cellavision DM1200 for use in medium-size laboratories. The Cellavision body fluid application has been available on DM96 since 2008 and on DM1200 outside the USA since 2010.
In the USA, Cellavision sells its products via a local subsidiary and via two distribution partners.
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|Title Annotation:||US Food and Drug Administration|
|Publication:||Nordic Business Report|
|Article Type:||Brief article|
|Date:||Sep 27, 2011|
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