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FDA 510(k)

Panther Fusion GBS Assay

K号: K181156 · 2018-07-27

申请人Diagenode
决定日期2018-07-27
产品代码NJR
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决定实质等同

器械摘要

Panther Fusion GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diagenode. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181156. 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 Panther Fusion GBS Assay?

Panther Fusion GBS Assay is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Diagenode. The 510(k) number is K181156.

When did Panther Fusion GBS Assay receive FDA 510(k) clearance?

Panther Fusion GBS Assay received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181156.

Who is the listed applicant for Panther Fusion GBS Assay?

The FDA 510(k) record lists Diagenode as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Panther Fusion GBS Assay?

The FDA product code for Panther Fusion 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。

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

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, LLCK173725NeuMoDx GBS检测Neumodx Molecular, Inc.K173250Solana GBS检测。Quidel CorporationK170557GenePOC GBS LBGenepoc, Inc.

官方来源

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