FDA 510(k)

cobas® liat CT/NG/MG 遺傳子測試

K 號：K240197 · 2025-01-16

決定日期2025-01-16

產品代碼QEP

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 CT/NG/MG 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 2025-01-16 under 510(k) number K240197. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the cobas® liat CT/NG/MG nucleic acid test?

cobas® liat CT/NG/MG nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K240197.

When did cobas® liat CT/NG/MG nucleic acid test receive FDA 510(k) clearance?

cobas® liat CT/NG/MG nucleic acid test received FDA 510(k) clearance on 2025-01-16, under 510(k) number K240197.

Who is the listed applicant for cobas® liat CT/NG/MG 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 CT/NG/MG nucleic acid test?

The FDA product code for cobas® liat CT/NG/MG nucleic acid test is QEP.

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：QEP）

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。

K260917cobas CT/NG用於cobas 5800/6800/8800系統；cobas TV/MG用於cobas 5800/6800/8800系統Roche Molecular Systems, Inc.K253756cobas liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.K253759cobas liat CT/NG/MG 遺傳子測試Roche Molecular Systems, Inc.K251501維斯比醫療男性性健康檢測Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.

官方來源

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