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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test for esophageal varices
Definition A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing.
Product CodeSIO
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025 2026
0 0 0 0 0 0 1

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