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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastric emptying breath test
Definition Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.
Product CodePGE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
2 0 2 1 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Cairn Diagnostics II Feb-16-2021
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