Solana滴虫检测。
K号: K161182 · 2016-08-15
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决定日期2016-08-15
产品代码OUY
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器械摘要
Solana Trichomonas 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 2016-08-15 under 510(k) number K161182. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solana Trichomonas Assay?
Solana Trichomonas Assay is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is Quidel Corporation. The 510(k) number is K161182.
When did Solana Trichomonas Assay receive FDA 510(k) clearance?
Solana Trichomonas Assay received FDA 510(k) clearance on 2016-08-15, under 510(k) number K161182.
Who is the listed applicant for Solana Trichomonas 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 Trichomonas Assay?
The FDA product code for Solana Trichomonas Assay is OUY.
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：OUY）
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。
K231316Aptima Trichomonas vaginalis AssayHologic, Inc.K182692BD MAX CTGCTV2, BD MAX 系统Becton, Dickinson and CompanyK151589BD MAX CT/GC/TV, BD MAX 仪器Becton, Dickinson and CompanyK161619Xpert TV，Xpert 尿标本采集套装，GeneXpert Dx 系统（GX-I，GX-II，GX-IV，GX-XVI），GeneXpert Infinity-48，Genxpert Infinity-48s 和 GeneXpert Infinity-80 系统Cepheid
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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