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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, colorectal neoplasia, rna markers and hemoglobin detection
Definition The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy.
Product CodeSBB
Device Class 3

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

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