Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Opioid use disorder genetic risk variant detection system and collection kit

PMA Number: P230032 · 2026-05-20

ApplicantAutoGenomics, Inc.
Decision Date2026-05-20
PMA NumberP230032
Product CodeQZH
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeTX

Device Summary

Opioid use disorder genetic risk variant detection system and collection kit is the device name listed in this FDA 510(k) record. The listed applicant is AutoGenomics, Inc.. It received FDA 510(k) clearance on 2026-05-20. The device is classified under product code QZH. It was reviewed by the TX advisory panel.

Frequently Asked Questions

What is the Opioid use disorder genetic risk variant detection system and collection kit?

Opioid use disorder genetic risk variant detection system and collection kit is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is AutoGenomics, Inc..

When did Opioid use disorder genetic risk variant detection system and collection kit receive FDA 510(k) clearance?

The clearance date for Opioid use disorder genetic risk variant detection system and collection kit can be found in the official FDA records.

Who is the listed applicant for Opioid use disorder genetic risk variant detection system and collection kit?

The FDA 510(k) record lists AutoGenomics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Opioid use disorder genetic risk variant detection system and collection kit?

The FDA product code for Opioid use disorder genetic risk variant detection system and collection kit is QZH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑