FDA 510(k)

ARCHITECT HSV-1 IgG，ARCHITECT HSV-1 IgG 校准劑，ARCHITECT HSV-1 IgG 控制劑

K 號：K213987 · 2023-09-20

決定日期2023-09-20

產品代碼MXJ

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

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls 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 2023-09-20 under 510(k) number K213987. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Biokit, S.A.. The 510(k) number is K213987.

When did ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls receive FDA 510(k) clearance?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls received FDA 510(k) clearance on 2023-09-20, under 510(k) number K213987.

Who is the listed applicant for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

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 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

The FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is MXJ.

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 K214068量體IgE K181334ADVIA Centaur 布隆氏疱疹病毒-2 IgG K181333ADVIA Centaur 布隆氏疱疹病毒-1 IgG

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相關器械（代碼：MXJ）

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。

K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics K181333ADVIA Centaur 布隆氏疱疹病毒-1 IgGBiokit, S.A.K162276SeraQuest 奇異型1特異性IgGQuest International, Inc.

官方來源

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