FDA 510(k)

防伯氏疏螺旋体US EUROLINE-WB (IgM)

K 號：K172722 · 2017-12-10

決定日期2017-12-10

產品代碼LSR

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

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) 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 2017-12-10 under 510(k) number K172722. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is a medical device that received FDA 510(k) clearance on 2017-12-10. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172722.

When did Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) receive FDA 510(k) clearance?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) received FDA 510(k) clearance on 2017-12-10, under 510(k) number K172722.

Who is the listed applicant for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

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 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

The FDA product code for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is LSR.

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 K153308歐瑞姆免疫抗西尼羅病毒ELISA（IgM）

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相關器械（代碼：LSR）

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。

K254295索菲亞萊姆FIA；索菲亞2攝氏菌FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG測試；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot 套件Id-Fish Technology, Inc.K233367iDart Lyme IgG 免疫Blot 套件Id-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合Zeus Scientific K220016維拉美德 Borrela 全功能 ViraChip 檢測套件Viramed Biotech AG

官方來源

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