FDA 510(k)

ADVIA Centaur 布隆氏疱疹病毒-2 IgG

K 號：K181334 · 2018-08-23

決定日期2018-08-23

產品代碼MYF

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 Herpes-2 IgG 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 2018-08-23 under 510(k) number K181334. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur Herpes-2 IgG?

ADVIA Centaur Herpes-2 IgG is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Biokit, S.A.. The 510(k) number is K181334.

When did ADVIA Centaur Herpes-2 IgG receive FDA 510(k) clearance?

ADVIA Centaur Herpes-2 IgG received FDA 510(k) clearance on 2018-08-23, under 510(k) number K181334.

Who is the listed applicant for ADVIA Centaur Herpes-2 IgG?

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 Herpes-2 IgG?

The FDA product code for ADVIA Centaur Herpes-2 IgG is MYF.

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 K233606ADVIA Centaur EBV-VCA IgM 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

查看所有 8 項裝置 →

相關器械（代碼：MYF）

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Biokit, S.A.K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics K181514SeraQuest 奈瑟氏病毒2型特異性IgGQuest International, Inc.K152353SeraQuest 奈瑟氏病毒2型特異性IgGQuest International, Inc.

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。