PMA P230032S003
- Device
- AvertD™ and AvertD™ Buccal Sample Collection Kit
- Applicant
- AutoGenomics, Inc.
- PMA number
- P230032
- Supplement
- S003
- Product code
- QZH
- Decision date
- 2026-01-29
- Classification
- Clinical Toxicology
- Generic name
- Opioid use disorder genetic risk variant detection system and collection kit
- Approval order statement
- Approval of changes to the clinical protocol for the post-approval study (PAS) for P230032.
Current openFDA PMA Record#
- Device
- AvertD™ and AvertD™ Buccal Sample Collection Kit
- Applicant
- AutoGenomics, Inc.
- PMA number
- P230032
- Supplement
- S003
- Product code
- QZH
- Generic name
- Opioid use disorder genetic risk variant detection system and collection kit
- Decision date
- 2026-01-29
- Decision code
- APPR
- Date received
- 2025-12-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of changes to the clinical protocol for the post-approval study (PAS) for P230032.