Product code QWQ
- Device name
- Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset