PMA
P190033: AAV5 DetectCDx
FDA PMA · Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors · ARUP Laboratories
Key facts
| PMA number | P190033 |
|---|---|
| Trade name | AAV5 DetectCDx |
| Generic name | Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors |
| Applicant | ARUP Laboratories |
| Product code | QWQ |
| Approval date | Jun 29, 2023 |
| Docket number | 23M-3055 |
| Notice date | Sep 18, 2023 |
| FEI number | 3008974012 |
At a glance
- 1–9 Supplements
- Oct 4, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: