FDA 510(k)

Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統

K 號：K221160 · 2022-06-07

決定日期2022-06-07

產品代碼PQA

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

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K221160. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Cepheid. The 510(k) number is K221160.

When did Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System receive FDA 510(k) clearance?

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System received FDA 510(k) clearance on 2022-06-07, under 510(k) number K221160.

Who is the listed applicant for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

FDA 510(k) 記錄將 Cepheid 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System?

The FDA product code for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is PQA.

其他以 Cepheid 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。

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相關器械（代碼：PQA）

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。

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD 阴道面板Becton, Dickinson and Company K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP；GeneXpert Xpress 系統Cepheid K223653BD 阴道面板Becton, Dickinson and Company K212213Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid

官方來源

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