Solana GBS检测。
K号: K173250 · 2017-12-21
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决定日期2017-12-21
产品代码NJR
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决定实质等同
器械摘要
Solana GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K173250. 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 Solana GBS Assay?
Solana GBS Assay is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Quidel Corporation. The 510(k) number is K173250.
When did Solana GBS Assay receive FDA 510(k) clearance?
Solana GBS Assay received FDA 510(k) clearance on 2017-12-21, under 510(k) number K173250.
Who is the listed applicant for Solana GBS Assay?
The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solana GBS Assay?
The FDA product code for Solana 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Quidel Corporation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 AssayDiagenodeK173725NeuMoDx GBS检测Neumodx Molecular, Inc.K170557GenePOC 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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