PMA
P250002: Quest Diagnostics AAVrh74 Antibody ELISA CDx
FDA PMA · Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors · Quest Diagnostics Nichols Institute
Key facts
| PMA number | P250002 |
|---|---|
| Trade name | Quest Diagnostics AAVrh74 Antibody ELISA CDx |
| Generic name | Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors |
| Applicant | Quest Diagnostics Nichols Institute |
| Owner/operator | QUEST DIAGNOSTICS INCORPORATED |
| Product code | QWQ |
| Approval date | Jul 24, 2025 |
| Establishment registration | 3007521501 |
| FEI number | 3005010397 |
At a glance
- None Supplements
- Jul 24, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: