ePlex 呼吸道病原体检测板
K号: K163636 · 2017-06-09
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决定日期2017-06-09
产品代码OCC
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器械摘要
ePlex Respiratory Pathogen Panel is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K163636. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ePlex Respiratory Pathogen Panel?
ePlex Respiratory Pathogen Panel is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K163636.
When did ePlex Respiratory Pathogen Panel receive FDA 510(k) clearance?
ePlex Respiratory Pathogen Panel received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163636.
Who is the listed applicant for ePlex Respiratory Pathogen Panel?
The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ePlex Respiratory Pathogen Panel?
The FDA product code for ePlex Respiratory Pathogen Panel is OCC.
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Genmark Diagnostics, Incorporated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：OCC）
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。
K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原体检测板 (RPP)Applied BioCode, Inc.K242613NxTAG®呼吸道病原体检测板Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas流感A/B & RSV核酸检测，适用于cobas Liat系统Roche Molecular Systems, 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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