Solana Bordetella完整检测。
K号: K181029 · 2018-07-15
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决定日期2018-07-15
产品代码OZZ
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器械摘要
Solana Bordetella 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 2018-07-15 under 510(k) number K181029. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solana Bordetella Complete Assay?
Solana Bordetella Complete Assay is a medical device that received FDA 510(k) clearance on 2018-07-15. The listed applicant is Quidel Corporation. The 510(k) number is K181029.
When did Solana Bordetella Complete Assay receive FDA 510(k) clearance?
Solana Bordetella Complete Assay received FDA 510(k) clearance on 2018-07-15, under 510(k) number K181029.
Who is the listed applicant for Solana Bordetella 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 Bordetella Complete Assay?
The FDA product code for Solana Bordetella Complete Assay is OZZ.
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：OZZ）
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。
K243753科博斯利亚特博德特菌核酸检测板Roche Molecular Systems, Inc.K183223Simplexa 博德特菌直接检测，Simplexa 博德特菌阳性对照包Diasorin Molecular, LLCK173498Simplexa 博德特菌直接检测，Simplexa 博德特菌阳性对照包Diasorin Molecular, LLCK163626ARIES 博德特菌检测；ARIES 博德特菌检测方案文件包Luminex CorporationK170284Great Basin Bordetella Direct TestGreat Basin Scientific, 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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