FDA 510(k)

cobas SARS-CoV-2 定性检测，适用于 cobas 5800/6800/8800 系统

K号: K231306 · 2023-06-01

决定日期2023-06-01

产品代码QQX

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决定实质等同

器械摘要

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems 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 2023-06-01 under 510(k) number K231306. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems?

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K231306.

When did cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems receive FDA 510(k) clearance?

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems received FDA 510(k) clearance on 2023-06-01, under 510(k) number K231306.

Who is the listed applicant for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems?

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 SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems?

The FDA product code for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems is QQX.

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。

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）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）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

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