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 Code | QWQ |
Device Class |
3
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Premarket Approvals (PMA) |
2009 |
2010 |
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2020 |
2021 |
2022 |
2023 |
2024 |
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1
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