PMA
P230032: AvertD and AvertD Buccal Sample Collection Kit
FDA PMA · Opioid use disorder genetic risk variant detection system and collection kit · AutoGenomics, Inc.
Key facts
| PMA number | P230032 |
|---|---|
| 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. |
| Owner/operator | Prescient Medicine Holdings Inc DBA SOLVD Health |
| Product code | QZH |
| Approval date | Dec 19, 2023 |
| Docket number | 23M-5501 |
| Notice date | Dec 19, 2023 |
| Establishment registration | 3005406097 |
| FEI number | 3005406097 |
At a glance
- 1–9 Supplements
- May 20, 2026 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- No Withdrawn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: