QWQ

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Product code

QWQ

Device name

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).