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FDA 510(k)

ARIES C. difficile 試劑完整套件，ARIES C. difficile 試劑實驗方案文件套件，ARIES C. difficile 試劑套件（24 套），ARIES 粪便再懸浮套件

K 號：K171441 · 2017-07-21

申請人Luminex Corporation
決定日期2017-07-21
產品代碼OZN
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

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171441. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Luminex Corporation. The 510(k) number is K171441.

When did ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit receive FDA 510(k) clearance?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171441.

Who is the listed applicant for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA 510(k) record lists Luminex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is OZN.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Luminex Corporation 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。

K253722LIAISON PLEX 消化道柔軟性試驗K243490LIAISON PLEX 革蘭氏陽性血液培養試劑K243013LIAISON PLEX 革蘭氏陰細菌血液培養試劑K240627LIAISON PLEX 酵母血培養試劑K233410LIAISON PLEX 呼吸道 Flex 檢驗試劑K191742ARIES MRSA 試劑

查看所有 13 項裝置 →

相關器械（代碼：OZN）

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。

K260045cobas® Cdiff 鈾酸測試，用於cobas® Liat® 系統（07454945190）；cobas® Cdiff 阳性及陰性控制組合包，用於cobas® Liat® 系統（07454970190）Roche Molecular Systems, Inc.K243730Xpert 褻敗桿菌/大腸桿菌抗藥性檢測器Cepheid®K232092大盆地產生毒素C. difficile直接測試（CDF2）Vela Operations USAK212427cobas Cdiff 遺傳子測試，適用於 cobas Liat 系統Roche Molecular Systems, Inc.K210385cobas Cdiff 遺傳子測試，適用於 cobas Liat 系統Roche Molecular Systems, Inc.K172569基因POC CDiffGenepoc, Inc.

官方來源

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