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FDA 510(k)

BD CTGCTV2

K 號：K243343 · 2025-04-22

申請人Bd Integrated Diagnostic Solutions/Becton,
決定日期2025-04-22
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

BD CTGCTV2 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243343. 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 BD CTGCTV2?

BD CTGCTV2 is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. The 510(k) number is K243343.

When did BD CTGCTV2 receive FDA 510(k) clearance?

BD CTGCTV2 received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243343.

Who is the listed applicant for BD CTGCTV2?

The FDA 510(k) record lists Bd Integrated Diagnostic Solutions/Becton, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD CTGCTV2?

The FDA product code for BD CTGCTV2 is QEP.

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。

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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.K253759cobas liat CT/NG/MG 遺傳子測試Roche Molecular Systems, Inc.K253756cobas liat CT/NG 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.K240217cobas® liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.K240197cobas® liat CT/NG/MG 遺傳子測試Roche Molecular Systems, Inc.

官方來源

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