結核分枝桿菌，細胞介導免疫反應，酶聯免疫斑點檢測
PMA 核准號：P070006 · 2025-08-04
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決定日期2025-08-04
PMA 編號P070006
產品代碼OJN
器械分類3 類
醫療專科U
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
器材摘要
Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Immunotec, Ltd.. It received FDA 510(k) clearance on 2025-08-04. The device is classified under product code OJN. It was reviewed by the MI advisory panel.
常見問題
What is the Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Oxford Immunotec, Ltd..
When did Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test receive FDA 510(k) clearance?
The clearance date for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test can be found in the official FDA records.
Who is the listed applicant for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
The FDA 510(k) record lists Oxford Immunotec, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test?
The FDA product code for Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test is OJN.
相關臨床試驗
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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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