Medical Letter on the CDC & FDA
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Diagnostics
U.S. FDA grants 510(k) clearance for blood screening controls
July 24th, 2005
AcroMetrix Corporation, a provider of quality controls for clinical diagnostic and blood testing laboratories, announced that it as received 510(k) clearance from the U.S. Food and Drug Administration for the VeriSure Pro External Quality Controls. These controls are for use on Chiron's Procleix blood testing system that is U.S. Food & Drug Administration (FDA) approved for the testing of HIV-1 and HCV using nucleic acid amplification. The clearance from the FDA allows the controls to be marketed and sold in the United States "for in vitro diagnostic use." "AcroMetrix is pleased to have received such an important clearance for the VeriSure external...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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