Solana HSV 1+2/VZV检测。
K号: K162451 · 2016-11-28
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决定日期2016-11-28
产品代码PGI
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器械摘要
Solana HSV 1+2/VZV 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 2016-11-28 under 510(k) number K162451. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solana HSV 1+2/VZV Assay?
Solana HSV 1+2/VZV Assay is a medical device that received FDA 510(k) clearance on 2016-11-28. The listed applicant is Quidel Corporation. The 510(k) number is K162451.
When did Solana HSV 1+2/VZV Assay receive FDA 510(k) clearance?
Solana HSV 1+2/VZV Assay received FDA 510(k) clearance on 2016-11-28, under 510(k) number K162451.
Who is the listed applicant for Solana HSV 1+2/VZV 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 HSV 1+2/VZV Assay?
The FDA product code for Solana HSV 1+2/VZV Assay is PGI.
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：PGI）
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。
K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器Quidel CorporationK192376Simplexa VZV 棉签直接检测，Simplexa VZV 阳性对照包Diasorin Molecular, LLCK180559HSV 1 & 2 ELITe MGB 套件; ELITe InGeniusElitechgroupK173798Simplexa HSV 1 & 2 直接检测，Simplexa HSV 1 & 2 阳性对照包Diasorin Molecular, LLC
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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