Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2021 2022 2023 2024 2025 2026
0 1 1 1 2 1

MDR Year MDR Reports MDR Events
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 2 2
Patient Device Interaction Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Vomiting 2 2
Abdominal Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Dizziness 1 1
Presyncope 1 1
Muscle Weakness 1 1
Constipation 1 1

-
-