QWQ · Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
· Class 3
Overview
| Product Code | QWQ |
|---|---|
| Device Name | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250002 | Quest Diagnostics AAVrh74 Antibody ELISA CDx | Quest Diagnostics Nichols Institute | Jul 24, 2025 | APPR |
| P190033 | AAV5 DetectCDx | ARUP Laboratories | Jun 29, 2023 | APPR |
Top Applicants
- ARUP Laboratories — 1 clearance
- Quest Diagnostics Nichols Institute — 1 clearance
