Medical Devices - The Urea Breath Test (UBT)
Otsuka Urea Breath Test System
(13C-Urea Breath Test)
Description
The 13C-urea breath test discovered by Otsuka Japan is a diagnostic agent that measures 13C-Urea in the breath to detect the presence of Helicobacter pylori (H. pylori), a class I carcinogen that may be a contributing factor to gastric cancer, in the stomach.
The US-FDA-approved product is currently the most reliable noninvasive diagnostic test for Helicobacter pylori infection and is considered to be a 'gold standard' for confirming the efficacy of H. pylori eradication therapy.
The 13C-urea breath test (UBIT) Kit is for administration by a healthcare professional, as ordered by a licensed healthcare practitioner.
Composition
UBIT Tablets are film-coated tablets, each containing 100 mg of urea (13C).
Indication
The 13C-urea breath test for H. Pylori Kit (UBIT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach. It is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection.