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FDA PMA

測試、免疫、細胞介導、結核分枝桿菌病

PMA 核准號:P010033 · 2026-01-23

申請人Qiagen
決定日期2026-01-23
PMA 編號P010033
產品代碼NCD
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

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen. It received FDA 510(k) clearance on 2026-01-23. The device is classified under product code NCD. It was reviewed by the MI advisory panel.

常見問題

What is the TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS?

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Qiagen.

When did TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS receive FDA 510(k) clearance?

The clearance date for TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS can be found in the official FDA records.

TEST、IMMUNITY、CELL MEDIATED、結核分枝桿菌病的申請人名單是誰?

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

FDA產品代碼為TEST、IMMUNITY、CELL MEDIATED、MYCOBACTERIUM TUBERCULOSIS的是什麼?

FDA產品代碼對TEST、IMMUNITY、CELL MEDIATED、MYCOBACTERIUM TUBERCULOSIS為NCD。

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

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