FDA 510(k)

歐瑞姆免疫抗西尼羅病毒ELISA（IgG）

K 號：K153303 · 2016-08-10

決定日期2016-08-10

產品代碼NOP

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

EUROIMMUN Anti-West Nile Virus ELISA (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K153303. The device is classified under product code NOP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EUROIMMUN Anti-West Nile Virus ELISA (IgG)?

EUROIMMUN Anti-West Nile Virus ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K153303.

When did EUROIMMUN Anti-West Nile Virus ELISA (IgG) receive FDA 510(k) clearance?

EUROIMMUN Anti-West Nile Virus ELISA (IgG) received FDA 510(k) clearance on 2016-08-10, under 510(k) number K153303.

Who is the listed applicant for EUROIMMUN Anti-West Nile Virus ELISA (IgG)?

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

What is the FDA product code for EUROIMMUN Anti-West Nile Virus ELISA (IgG)?

The FDA product code for EUROIMMUN Anti-West Nile Virus ELISA (IgG) is NOP.

其他以 Euroimmun Us, 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。

K193115EUROIMMUN 防止-BP230-CF 適合性免疫測試 (IgG)K183313EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgA)，EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgG)K172582歐瑞姆免疫 IFA 粒性細胞嵌合體™ EUROPattern 及歐瑞姆免疫 EUROPLUS 粒性細胞嵌合體™ EUROPattern K172244EUROIMMUN IFA：克氏次蟲（抗-dsDNA）EUROPattern K172252EUROIMMUN IFA：克氏毛蟻蟻敏感（抗-dsDNA）EUROPattern K172722防伯氏疏螺旋体US EUROLINE-WB (IgM)

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相關器械（代碼：NOP）

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。

K153308歐瑞姆免疫抗西尼羅病毒ELISA（IgM）Euroimmun Us, Inc.

官方來源

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