FDA 510(k)

Xpert® Xpress CoV-2 plus

K 號：K230440 · 2023-10-13

決定日期2023-10-13

產品代碼QQX

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 CoV-2 plus is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230440. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert® Xpress CoV-2 plus?

Xpert® Xpress CoV-2 plus is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Cepheid®. The 510(k) number is K230440.

When did Xpert® Xpress CoV-2 plus receive FDA 510(k) clearance?

Xpert® Xpress CoV-2 plus received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230440.

Who is the listed applicant for Xpert® Xpress CoV-2 plus?

The FDA 510(k) record lists Cepheid® as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xpert® Xpress CoV-2 plus?

The FDA product code for Xpert® Xpress CoV-2 plus is QQX.

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：QQX）

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。

K243396Aptima SARS-CoV-2 檢測試劑Hologic, Inc.K240867cobas® SARS-CoV-2 定性檢測用於 cobas® 5800/6800/8800 系統Roche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular K233453Applied Biosystems™ TaqPath™ COVID-19 诊断PCR試劑套件Life Technologies Corporation K231306cobas SARS-CoV-2 定性檢測，適用於cobas 5800/6800/8800 系統Roche Molecular Systems, Inc.

官方來源

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