PMA supplement
P230032 S004: AvertD and AvertD Buccal Sample Collection Kit
FDA PMA supplement · Real-Time Process · AutoGenomics, Inc.
Key facts
| Original PMA | P230032 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | AvertD and AvertD Buccal Sample Collection Kit |
| Generic name | Opioid use disorder genetic risk variant detection system and collection kit |
| Applicant | AutoGenomics, Inc. |
| Product code | QZH |
| Received date | Jan 9, 2026 |
| Decision date | Apr 10, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: