FDA 510(k)

Alinity m EBV (09N43-095)

K 號：K243489 · 2025-07-28

決定日期2025-07-28

產品代碼QLX

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Alinity m EBV (09N43-095) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-07-28 under 510(k) number K243489. The device is classified under product code QLX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity m EBV (09N43-095)?

Alinity m EBV (09N43-095) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K243489.

When did Alinity m EBV (09N43-095) receive FDA 510(k) clearance?

Alinity m EBV (09N43-095) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K243489.

Who is the listed applicant for Alinity m EBV (09N43-095)?

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

What is the FDA product code for Alinity m EBV (09N43-095)?

The FDA product code for Alinity m EBV (09N43-095) is QLX.

其他以 Abbott Molecular, Inc. 為申請人之記錄

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。

K252102Alinity m HCV K243485Alinity m CMV K241921Alinity m BKV K241573Alinity m Resp-4-Plex K233349Alinity m HSV 1 & 2 / VZV K222379Alinity m STI Assay

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相關器械（代碼：QLX）

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。

K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)Abbott Molecular, Inc.K203220cobas BKVRoche Molecular Systems, Inc.

官方來源

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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。