FDA 510(k)

cobas liat 布氏菌屬核酸檢測面板

K 號：K243753 · 2025-11-20

決定日期2025-11-20

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

cobas liat Bordetella panel nucleic acid test is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K243753. 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 cobas liat Bordetella panel nucleic acid test?

cobas liat Bordetella panel nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K243753.

When did cobas liat Bordetella panel nucleic acid test receive FDA 510(k) clearance?

cobas liat Bordetella panel nucleic acid test received FDA 510(k) clearance on 2025-11-20, under 510(k) number K243753.

Who is the listed applicant for cobas liat Bordetella panel nucleic acid test?

FDA 510(k) 記錄將羅氏分子系統公司（Roche Molecular Systems, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for cobas liat Bordetella panel nucleic acid test?

The FDA product code for cobas liat Bordetella panel nucleic acid test is OZZ.

其他以 Roche Molecular Systems, 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。

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）K260047cobas Strep A 鈾酸測試，用於 cobas Liat 系統（07341911190）；cobas Strep A 質量控制套件（07402678190）K260021cobas® BV/CV K260917cobas CT/NG用於cobas 5800/6800/8800系統；cobas TV/MG用於cobas 5800/6800/8800系統 K253756cobas liat CT/NG 遺傳子測試 K253759cobas liat CT/NG/MG 遺傳子測試

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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。

K183223Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLC K173498Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLC K181029索拉納波多氏菌完整試驗Quidel Corporation K163626ARIES 博德特菌試劑；ARIES 博德特菌試劑實驗方案文件套件Luminex Corporation K170284Great Basin Bordetella直接測試Great Basin Scientific, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。