FDA 510(k)

cobas® CT/NG v2.0 測試

K 號：K163184 · 2017-02-09

決定日期2017-02-09

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

cobas® CT/NG v2.0 Test is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163184. 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 cobas® CT/NG v2.0 Test?

cobas® CT/NG v2.0 Test is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K163184.

When did cobas® CT/NG v2.0 Test receive FDA 510(k) clearance?

cobas® CT/NG v2.0 Test received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163184.

Who is the listed applicant for cobas® CT/NG v2.0 Test?

FDA 510(k) 記錄將羅氏分子系統公司（Roche Molecular Systems, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for cobas® CT/NG v2.0 Test?

The FDA product code for cobas® CT/NG v2.0 Test is LSL.

其他以 Roche Molecular Systems, Inc. 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。

K260047cobas Strep A 鈾酸測試，用於 cobas Liat 系統（07341911190）；cobas Strep A 質量控制套件（07402678190）K260045cobas® Cdiff 鈾酸測試，用於cobas® Liat® 系統（07454945190）；cobas® Cdiff 阳性及陰性控制組合包，用於cobas® Liat® 系統（07454970190）K260021cobas® BV/CV K260917cobas CT/NG用於cobas 5800/6800/8800系統；cobas TV/MG用於cobas 5800/6800/8800系統 K253756cobas liat CT/NG 遺傳子測試 K253759cobas liat CT/NG/MG 遺傳子測試

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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.K173840Xpert CT/NGCepheid

官方來源

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