ARIES GBS 检测
K号: K162772 · 2016-12-23
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决定日期2016-12-23
产品代码NJR
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器械摘要
ARIES GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K162772. 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 ARIES GBS Assay?
ARIES GBS Assay is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Luminex Corporation. The 510(k) number is K162772.
When did ARIES GBS Assay receive FDA 510(k) clearance?
ARIES GBS Assay received FDA 510(k) clearance on 2016-12-23, under 510(k) number K162772.
Who is the listed applicant for ARIES GBS Assay?
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 GBS Assay?
The FDA product code for ARIES 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。
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.K173250Solana GBS检测。Quidel Corporation
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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