阿片類使用障礙遺傳風險變異檢測系統及收集套件
PMA 核准號：P230032 · 2026-05-20
廣告
決定日期2026-05-20
PMA 編號P230032
產品代碼QZH
器械分類3 類
醫療專科U
諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：
本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。
器材摘要
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.
常見問題
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.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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