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FDA 510(k)

ARIES 博德特菌試劑；ARIES 博德特菌試劑實驗方案文件套件

K 號：K163626 · 2017-05-02

申請人Luminex Corporation
決定日期2017-05-02
產品代碼OZZ
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 Bordetella Assay; ARIES Bordetella Assay Protocol File 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 2017-05-02 under 510(k) number K163626. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Luminex Corporation. The 510(k) number is K163626.

When did ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit receive FDA 510(k) clearance?

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit received FDA 510(k) clearance on 2017-05-02, under 510(k) number K163626.

Who is the listed applicant for ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File 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 Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

The FDA product code for ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is OZZ.

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

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相關器械（代碼：OZZ）

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。

K243753cobas liat 布氏菌屬核酸檢測面板Roche Molecular Systems, Inc.K183223Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLCK173498Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLCK181029索拉納波多氏菌完整試驗Quidel CorporationK170284Great Basin Bordetella直接測試Great Basin Scientific, Inc.

官方來源

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