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This article was originally published in The Gray Sheet
HIV-1 antibody test gains a CLIA waiver for use with venous whole blood samples, expanding its market potential to about 180,000 hospitals, physician offices and clinics. The 10-minute test received PMA approval in December 2003 for use with serum, plasma and whole blood. A finger-stick whole blood claim is pending at FDA (1"The Gray Sheet" Jan. 5, 2004, p. 6)...
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