FDA 510(k)

Alinity m STI Assay

K 號：K222379 · 2023-03-03

決定日期2023-03-03

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

Alinity m STI Assay is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K222379. 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 Alinity m STI Assay?

Alinity m STI Assay is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K222379.

When did Alinity m STI Assay receive FDA 510(k) clearance?

Alinity m STI Assay received FDA 510(k) clearance on 2023-03-03, under 510(k) number K222379.

Who is the listed applicant for Alinity m STI Assay?

The FDA 510(k) record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity m STI Assay?

The FDA product code for Alinity m STI Assay is QEP.

其他以 Abbott Molecular, 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。

K252102Alinity m HCV K243489Alinity m EBV (09N43-095)K243485Alinity m CMV K241921Alinity m BKV K241573Alinity m Resp-4-Plex K233349Alinity m HSV 1 & 2 / VZV

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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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