FDA 510(k)

EUROIMMUN IFA：克氏次蟲（抗-dsDNA）EUROPattern

K 號：K172244 · 2018-04-20

決定日期2018-04-20

產品代碼KTL

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern 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 2018-04-20 under 510(k) number K172244. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern?

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172244.

When did EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern receive FDA 510(k) clearance?

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern received FDA 510(k) clearance on 2018-04-20, under 510(k) number K172244.

Who is the listed applicant for EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern?

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 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern?

The FDA product code for EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern is KTL.

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 K172252EUROIMMUN IFA：克氏毛蟻蟻敏感（抗-dsDNA）EUROPattern K172722防伯氏疏螺旋体US EUROLINE-WB (IgM)K153308歐瑞姆免疫抗西尼羅病毒ELISA（IgM）

查看所有 8 項裝置 →

相關器械（代碼：KTL）

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。

K231616ZEUS IFA™ nDNA測試系統，ZEUS dIFineZeus Scientific K203599Image Navigator by Immuno Concepts，Immuno Concepts IgG 抗-nDNA 荧光檢測系統Immuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae 套件Inova Diagnostics, Inc.K172252EUROIMMUN IFA：克氏毛蟻蟻敏感（抗-dsDNA）EUROPatternEuroimmun Us, Inc.

官方來源

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