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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors
Definition An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products.
Product CodeQWQ
Device Class 3

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

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