PMA P230032S002

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S002
Product code: QZH
Decision date: 2024-11-07
Classification: Clinical Toxicology
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Approval order statement: Approval for the addition of the INFINITI High-Throughput System (HTS) for use in analyzing samples with the AvertD test

Current openFDA PMA Record#

Device: AvertD and AvertD Buccal Sample Collection Kit
Applicant: AutoGenomics, Inc.
PMA number: P230032
Supplement: S002
Product code: QZH
Generic name: Opioid use disorder genetic risk variant detection system and collection kit
Decision date: 2024-11-07
Decision code: APPR
Date received: 2024-05-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of the INFINITI High-Throughput System (HTS) for use in analyzing samples with the AvertD test