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

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/QWQ

## Overview

- **Product Code:** QWQ
- **Device Name:** Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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](/device/P250002.md) | Quest Diagnostics AAVrh74 Antibody ELISA CDx | Quest Diagnostics Nichols Institute | Jul 24, 2025 | APPR |
| [P190033](/device/P190033.md) | AAV5 DetectCDx | ARUP Laboratories | Jun 29, 2023 | APPR |

## Top Applicants

- ARUP Laboratories — 1 clearance
- Quest Diagnostics Nichols Institute — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QWQ](https://fda.innolitics.com/productcode/QWQ)

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