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FDA 510(k)

ARIES 肠球菌检测完整试剂盒，ARIES 肠球菌检测方案文件包，ARIES 肠球菌检测试剂盒（24个卡盒），ARIES 粪便再悬浮试剂盒

K号: K171441 · 2017-07-21

申请人Luminex Corporation
决定日期2017-07-21
产品代码OZN
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决定实质等同

器械摘要

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171441. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Luminex Corporation. The 510(k) number is K171441.

When did ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit receive FDA 510(k) clearance?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171441.

Who is the listed applicant for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

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

What is the FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is OZN.

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 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。

K253722LIAISON PLEX 胃肠道灵活检测K243490LIAISON PLEX 革兰氏阳性血培养检测K243013LIAISON PLEX 革兰氏阴性血培养检测K240627LIAISON PLEX 酵母血培养检测K233410LIAISON PLEX 呼吸道灵活检测K191742ARIES MRSA 测试

查看所有 13 个设备 →

相关器械（代码：OZN）

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。

K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）Roche Molecular Systems, Inc.K243730Xpert 肠道难辨梭菌/流行病学Cepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USAK212427cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K210385cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, 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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