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FDA 510(k)

cobas流感A/B & RSV核酸检测，适用于cobas Liat系统

K号: K210234 · 2021-02-16

申请人Roche Molecular Systems, Inc.
决定日期2021-02-16
产品代码OCC
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决定实质等同

器械摘要

cobas Influenza A/B & RSV 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 2021-02-16 under 510(k) number K210234. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System?

cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K210234.

When did cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210234.

Who is the listed applicant for cobas Influenza A/B & RSV 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 Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System is OCC.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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/CVK260917cobas 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：OCC）

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。

K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原体检测板 (RPP)Applied BioCode, Inc.K242613NxTAG®呼吸道病原体检测板Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas流感A/B & RSV核酸检测，适用于cobas Liat系统Roche Molecular Systems, Inc.

官方来源

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