FDA 510(k)

Xpert CT/NG

K 號：K173840 · 2018-03-16

決定日期2018-03-16

產品代碼LSL

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 CT/NG is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K173840. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert CT/NG?

Xpert CT/NG is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Cepheid. The 510(k) number is K173840.

When did Xpert CT/NG receive FDA 510(k) clearance?

Xpert CT/NG received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173840.

Who is the listed applicant for Xpert CT/NG?

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 CT/NG?

The FDA product code for Xpert CT/NG is LSL.

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：LSL）

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。

K231329Aptima 黏膜壞死桿菌檢測試劑Hologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG用於cobas 6800/8800系統Roche Molecular Systems, Inc.K163184cobas® CT/NG v2.0 測試Roche Molecular Systems, Inc.

官方來源

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