檢測腺病毒病毒載體（AAV）預存抗體的試劑
PMA 核准號：P190033 · 2024-10-04
廣告
決定日期2024-10-04
PMA 編號P190033
產品代碼QWQ
器械分類3 類
醫療專科U
諮詢委員會HE
請提供完整的描述文本，以便我能夠進行翻譯。
器材摘要
Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is the device name listed in this FDA 510(k) record. The listed applicant is ARUP Laboratories. It received FDA 510(k) clearance on 2024-10-04. The device is classified under product code QWQ. It was reviewed by the HE advisory panel.
常見問題
What is the Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is ARUP Laboratories.
When did Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors receive FDA 510(k) clearance?
The clearance date for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors can be found in the official FDA records.
Who is the listed applicant for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
The FDA 510(k) record lists ARUP Laboratories as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors?
The FDA product code for Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors is QWQ.
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。
廣告