QWQ — Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors Class III
FDA product code QWQ covers "Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QWQ
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
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.