FDA 510(k)

ADVIA Centaur EBV-VCA IgM

K 號：K233606 · 2024-08-07

決定日期2024-08-07

產品代碼LSE

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

ADVIA Centaur EBV-VCA IgM is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K233606. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur EBV-VCA IgM?

ADVIA Centaur EBV-VCA IgM is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Biokit, S.A.. The 510(k) number is K233606.

When did ADVIA Centaur EBV-VCA IgM receive FDA 510(k) clearance?

ADVIA Centaur EBV-VCA IgM received FDA 510(k) clearance on 2024-08-07, under 510(k) number K233606.

Who is the listed applicant for ADVIA Centaur EBV-VCA IgM?

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

What is the FDA product code for ADVIA Centaur EBV-VCA IgM?

The FDA product code for ADVIA Centaur EBV-VCA IgM is LSE.

其他以 Biokit, S.A. 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。

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG校准器, ARCHITECT HSV-2 IgG控制 K233605ADVIA Centaur EBV-EBNA IgG K213987ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG 校准劑，ARCHITECT HSV-1 IgG 控制劑 K214068量體IgE K181333ADVIA Centaur 布隆氏疱疹病毒-1 IgG K181334ADVIA Centaur 布隆氏疱疹病毒-2 IgG

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相關器械（代碼：LSE）

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。

K162961LIAISON® VCA IgG 及 LIAISON® VCA IgG 血清控制組合；LIAISON® EBNA IgG 及 LIAISON® EBNA IgG 血清控制組合DiaSorin, Inc.K162959LIAISON® EA IgG 及 LIAISON® EA IgG 血清控制組DiaSorin, Inc.

官方來源

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