FDA 510(k)

cobas Cdiff 核酸检测，适用于 cobas Liat 系统

K号: K210385 · 2021-09-09

决定日期2021-09-09

产品代码OZN

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决定实质等同

器械摘要

cobas Cdiff nucleic acid test for use on the cobas Liat System 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 2021-09-09 under 510(k) number K210385. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas Cdiff nucleic acid test for use on the cobas Liat System?

cobas Cdiff nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K210385.

When did cobas Cdiff nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas Cdiff nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2021-09-09, under 510(k) number K210385.

Who is the listed applicant for cobas Cdiff nucleic acid test for use on the cobas Liat System?

FDA 510(k)记录中列出罗氏分子系统有限公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System is OZN.

列明Roche Molecular Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）K260047cobas Strep A 核酸检测，用于cobas Liat系统（07341911190）；cobas Strep A 质量控制试剂盒（07402678190）K260021cobas® BV/CV K260917cobas CT/NG 用于 cobas 5800/6800/8800 系统；cobas TV/MG 用于 cobas 5800/6800/8800 系统 K253756cobas liat CT/NG 核酸检测 K253759科博斯利亚特CT/NG/MG核酸检测

查看所有 36 个设备 →

相关器械（代码：OZN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）Roche Molecular Systems, Inc.K243730Xpert 肠道难辨梭菌/流行病学Cepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA K212427cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.K171770cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.

官方来源

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