NeuMoDx GBS检测
K号: K173725 · 2018-06-26
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决定日期2018-06-26
产品代码NJR
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器械摘要
NeuMoDx GBS Assay 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 2018-06-26 under 510(k) number K173725. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeuMoDx GBS Assay?
NeuMoDx GBS Assay is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Neumodx Molecular, Inc.. The 510(k) number is K173725.
When did NeuMoDx GBS Assay receive FDA 510(k) clearance?
NeuMoDx GBS Assay received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173725.
Who is the listed applicant for NeuMoDx GBS Assay?
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 GBS Assay?
The FDA product code for NeuMoDx GBS Assay is NJR.
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：NJR）
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。
K222638Xpert® Xpress GBS，GeneXpert® Dx 系统，GeneXpert® Infinity 系统CepheidK203429Xpert GBS LB XC，GeneXpert Dx 系统，GeneXpert Infinity 系统CepheidK182467Simplexa GBS 直接检测，Simplexa GBS 阳性对照包Diasorin Molecular, LLCK181156Panther Fusion GBS AssayDiagenodeK173250Solana GBS检测。Quidel CorporationK170557GenePOC GBS LBGenepoc, 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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