Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
QWQ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QWQ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
IM
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.