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Applied Biosystems Inc.
Applied Biosystems Receives FDA 510k Clearance for Real-time PCR Instrument for Use with New Flu Test from U.S. Centers for Disease Control and Prevention
October 14th, 2008
Applied Biosystems Inc. (NYSE:ABI) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention. While both products received independent FDA 510(k) clearances, they are required to be used together as a system for the detection of influenza. Together with the 7500 Fast Dx Real-Time PCR Instrument, the new CDC diagnostic assay is designed to help standardize influenza virus testing and sub-typing and provide...
Source: TB & Outbreaks Week (2008-10-14)
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