HIV/AIDS Diagnostics
Life science company receives additional U.S. FDA clearance for quality controls
Published in Medical Letter on the CDC and FDA, January 2nd, 2005
The Accurun 315 HIV-1 RNA positive quality control includes a series of 5 controls, each with a different level of HIV RNA, and is cleared for use in the U.S. as an independent control for both diagnostic testing and blood screening. BBI Diagnostics has also obtained CE Mark approval for Accurun 315, a regulatory requirement for sales to European markets. With FDA clearance, BBI Diagnostics may now sell the same product worldwide.
SeraCare also announced that its...
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