FDA 510(k)

Xpert MRSA/SA 超敏細菌感染檢測器

K 號：K243625 · 2024-12-18

決定日期2024-12-18

產品代碼NQX

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 MRSA/SA SSTI is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243625. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert MRSA/SA SSTI?

Xpert MRSA/SA SSTI is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Cepheid®. The 510(k) number is K243625.

When did Xpert MRSA/SA SSTI receive FDA 510(k) clearance?

Xpert MRSA/SA SSTI received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243625.

Who is the listed applicant for Xpert MRSA/SA SSTI?

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 MRSA/SA SSTI?

The FDA product code for Xpert MRSA/SA SSTI is NQX.

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：NQX）

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。

K243070Xpert® SA 鼻腔完整版Cepheid®K191742ARIES MRSA 試劑Luminex Corporation K190771Xpert MRSA/SA 血液培養儀，GeneXpert Dx 系統，GeneXpert Infinity-48s 系統，GeneXpert Infinity-80 系統Cepheid K162444Xpert MRSA NxGCepheid

官方來源

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