PMA P230032S005

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S005
Product code: QZH
Decision date: 2026-05-20
Classification: Clinical Toxicology
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230032.

Current openFDA PMA Record#

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S005
Product code: QZH
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Decision date: 2026-05-20
Decision code: APPR
Date received: 2026-04-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230032.