Solana链球菌完整检测。
K号: K162274 · 2016-10-25
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决定日期2016-10-25
产品代码PGX
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器械摘要
Solana Strep Complete Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162274. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solana Strep Complete Assay?
Solana Strep Complete Assay is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Quidel Corporation. The 510(k) number is K162274.
When did Solana Strep Complete Assay receive FDA 510(k) clearance?
Solana Strep Complete Assay received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162274.
Who is the listed applicant for Solana Strep Complete Assay?
The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solana Strep Complete Assay?
The FDA product code for Solana Strep Complete Assay is PGX.
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Quidel 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：PGX）
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。
K260047cobas Strep A 核酸检测，用于cobas Liat系统（07341911190）；cobas Strep A 质量控制试剂盒（07402678190）Roche Molecular Systems, Inc.K260333LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件Diasorin Molecular, LLCK201269Accula Strep A TestMesa Biotech, Inc.K183366GenePOC Strep AGenepoc, Inc.K173653Alere i 链球菌A 2，Alere i 仪器，Alere i 链球菌A 2控制拭子套装Alere Scarborough, Inc.K173398Xpert Xpress 链球菌ACepheid
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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