NeuMoDx CT/NG检测2.0
K号: K230267 · 2023-12-22
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决定日期2023-12-22
产品代码QEP
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器械摘要
NeuMoDx CT/NG Assay 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Neumodx Molecular, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K230267. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeuMoDx CT/NG Assay 2.0?
NeuMoDx CT/NG Assay 2.0 is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Neumodx Molecular, Inc.. The 510(k) number is K230267.
When did NeuMoDx CT/NG Assay 2.0 receive FDA 510(k) clearance?
NeuMoDx CT/NG Assay 2.0 received FDA 510(k) clearance on 2023-12-22, under 510(k) number K230267.
Who is the listed applicant for NeuMoDx CT/NG Assay 2.0?
The FDA 510(k) record lists Neumodx Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeuMoDx CT/NG Assay 2.0?
The FDA product code for NeuMoDx CT/NG Assay 2.0 is QEP.
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。
列明Neumodx Molecular, 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。
相关器械（代码：QEP）
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。
K260917cobas CT/NG 用于 cobas 5800/6800/8800 系统；cobas TV/MG 用于 cobas 5800/6800/8800 系统Roche Molecular Systems, Inc.K253756cobas liat CT/NG 核酸检测Roche Molecular Systems, Inc.K253759科博斯利亚特CT/NG/MG核酸检测Roche Molecular Systems, Inc.K251501维斯比医疗男性性健康检测Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 核酸检测Roche Molecular Systems, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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