FDAnews Device Daily Bulletin

MERIDIAN BIOSCIENCE RECEIVES FDA CLIA WAIVER STATUS FOR STOMACH ULCER TEST

June 13, 2006
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Meridian Bioscience, Inc. today announced that it has received CLIA waiver status from the U.S. Food and Drug Administration (FDA) for its ImmunoCard STAT!(R) HpSA test, a rapid single-use test for the diagnosis of Helicobacter pylori (H. pylori) infection. The vast majority of peptic ulcer disease is caused by infection with H. pylori bacteria and, in recent years, effective therapies have become available for eradicating this disease. Peptic ulcer disease impacts millions of Americans resulting in more than $6 billion in healthcare costs each year.
Meridian Bioscience