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FDA 510(k)

xTAG 胃肠道病原体检测板（GPP），xTAG 数据分析软件（TDAS GPP）

K号: K183023 · 2018-11-30

申请人Luminex Molecular Diagnostics, Inc.
决定日期2018-11-30
产品代码PCH
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决定实质等同

器械摘要

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K183023. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K183023.

When did xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) receive FDA 510(k) clearance?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) received FDA 510(k) clearance on 2018-11-30, under 510(k) number K183023.

Who is the listed applicant for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is PCH.

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Luminex Molecular Diagnostics, 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。

K242613NxTAG®呼吸道病原体检测板K231758NxTAG呼吸道病原体检测板v2 (NxTAG RPP v2)K193167NxTAG呼吸道病原体检测板，NxTAG呼吸道病原体检测板文件，SYNCT软件K191161xTAG 胃肠道病原体检测板（GPP）K191160xTAG 胃肠道病原体检测板（GPP），xTAG 数据分析软件（TDAS GPP）K183030xTAG 胃肠道病原体检测板（GPP），xTAG 数据分析软件（TDAS GPP）

查看所有 10 个设备 →

相关器械（代码：PCH）

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。

K253722LIAISON PLEX 胃肠道灵活检测Luminex CorporationK254032QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI 面板CepheidK252329QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251868Panther Fusion GI Bacterial AssayHologicK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.

官方来源

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