High-Precision C13 Isotope Analyzer for Helicobacter pylori Testing

The C13 Urea Breath Test Analyzer, used in conjunction with the companion ¹³C-urea breath test reagent, is intended for the qualitative detection of urease enzyme activity associated with Helicobacter pylori (H. pylori) infection in the human stomach.

This diagnostic system serves as an adjunctive diagnostic aid for the initial diagnosis of H. pylori infection and for post-eradication therapy monitoring (retesting), with retesting recommended at 4 weeks or more after completion of therapy. The device is indicated for use in adult and pediatric patients.

This test should be performed by trained healthcare professionals under a physician's prescription. Test results must be interpreted in the context of the patient's clinical presentation and other laboratory findings.

Limitations: Insufficient clinical data are available to support use in patients with total or partial gastrectomy, pregnant women, or nursing mothers. Proton pump inhibitors, antibiotics, and bismuth preparations may interfere with test results and should be withheld prior to testing as specified in the product labeling.