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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorescence in situ hybridization, chromosome 17p deletion (tp53)
Definition A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).
Product CodePNK
Device Class 3

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

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