FDA 510(k)

Xpert Xpress MVP；GeneXpert Xpress 系統

K 號：K231381 · 2023-10-19

決定日期2023-10-19

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 Xpress System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2023-10-19 under 510(k) number K231381. 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 Xpress System?

Xpert Xpress MVP; GeneXpert Xpress System is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Cepheid. The 510(k) number is K231381.

When did Xpert Xpress MVP; GeneXpert Xpress System receive FDA 510(k) clearance?

Xpert Xpress MVP; GeneXpert Xpress System received FDA 510(k) clearance on 2023-10-19, under 510(k) number K231381.

Who is the listed applicant for Xpert Xpress MVP; GeneXpert Xpress 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 Xpress System?

The FDA product code for Xpert Xpress MVP; GeneXpert Xpress 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。

K261336Xpert 呼吸檢測組合 K261362Xpert 發熱出血熱 K261867Xpert 卡巴-R K253653Xpert 發熱出血熱 K251721Xpert GI Panel K250995Xpert Xpress CoV-2/流感/RSV 加

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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.K223653BD 阴道面板Becton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid K212213Xpert Xpress MVP, GeneXpert Dx 系統，GeneXpert Infinity 系統Cepheid

官方來源

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