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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, urea adult and pediatric (breath),
Regulation Description Campylobacter fetus serological reagents.
Definition Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.
Product CodeOZA
Regulation Number 866.3110
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 3 2 2 3 1

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