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The BreathTek UBT Kit is intended for the qualitative detection of urease associated with H. pylori in the human stomach to aid in the diagnosis and monitoring of H. pylori infection in adults and
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The medical device division refers to the division or department within an organization that is responsible for handling and overseeing medical devices.
Medical device manufacturers and distributors are typically required to file the medical device division.
To fill out the medical device division, you may need to provide information about the medical devices being manufactured or distributed, including their specifications, intended use, and any applicable certifications or regulatory compliance.
The purpose of the medical device division is to ensure that medical devices meet the necessary safety and quality standards, and to facilitate regulatory compliance and oversight.
The specific information required to be reported on the medical device division may vary depending on the regulations and requirements of the jurisdiction. However, it commonly includes details such as device description, manufacturing processes, labeling, adverse events, and post-market surveillance activities.
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