PMA P230032S004

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S004
Product code: QZH
Decision date: 2026-04-10
Classification: Clinical Toxicology
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Approval order statement: Approval for the addition of venous whole blood as sample type for use with the AvertD test.

Current openFDA PMA Record#

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S004
Product code: QZH
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-01-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of venous whole blood as sample type for use with the AvertD test.