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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),
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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 3 2 2 3 1 2 1 0 2 0 1 1 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 1 1
2021 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient Device Interaction Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Vomiting 3 3
Dizziness 1 1
Constipation 1 1
Presyncope 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Syncope 1 1
Abdominal Pain 1 1
Abortion 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Weakness 1 1
Nausea 1 1

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