FDA 510(k)

Xpert Xpress CoV-2/流感/RSV 加

K 號：K231481 · 2023-08-17

決定日期2023-08-17

產品代碼QOF

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/Flu/RSV plus is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2023-08-17 under 510(k) number K231481. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert Xpress CoV-2/Flu/RSV plus?

Xpert Xpress CoV-2/Flu/RSV plus is a medical device that received FDA 510(k) clearance on 2023-08-17. The listed applicant is Cepheid®. The 510(k) number is K231481.

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

Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance on 2023-08-17, under 510(k) number K231481.

Who is the listed applicant for Xpert Xpress CoV-2/Flu/RSV 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/Flu/RSV plus?

The FDA product code for Xpert Xpress CoV-2/Flu/RSV plus is QOF.

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：QOF）

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Cepheid K263054BIOFIRE 呼吸面板 2.1 (RP2.1)Biofire Diagnostics K261837FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K252932快速PCR迷你呼吸道面板Autonomous Medical Devices Incorporated K252269FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K251742VELO 呼吸測試Lex Diagnostics Limited

官方來源

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