FDA 510(k)

cobas Cdiff 遺傳子測試，適用於 cobas Liat 系統

K 號：K212427 · 2021-10-20

決定日期2021-10-20

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

cobas Cdiff nucleic acid test for use on the cobas Liat System 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 2021-10-20 under 510(k) number K212427. 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 cobas Cdiff nucleic acid test for use on the cobas Liat System?

cobas Cdiff nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K212427.

When did cobas Cdiff nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas Cdiff nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2021-10-20, under 510(k) number K212427.

Who is the listed applicant for cobas Cdiff nucleic acid test for use on the cobas Liat System?

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 Cdiff nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System is OZN.

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 K253759cobas liat CT/NG/MG 遺傳子測試 K253756cobas liat CT/NG 遺傳子測試

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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 USA K210385cobas Cdiff 遺傳子測試，適用於 cobas Liat 系統Roche Molecular Systems, Inc.K172569基因POC CDiffGenepoc, Inc.K171770cobas Cdiff 鈺酸測試，用於cobas Liat 系統Roche Molecular Systems, Inc.

官方來源

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