Sofia 流感A+B FIA
K号: K153012 · 2016-01-12
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决定日期2016-01-12
产品代码PSZ
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决定实质等同
器械摘要
Sofia Influenza A+B FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K153012. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sofia Influenza A+B FIA?
Sofia Influenza A+B FIA is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Quidel Corporation. The 510(k) number is K153012.
When did Sofia Influenza A+B FIA receive FDA 510(k) clearance?
Sofia Influenza A+B FIA received FDA 510(k) clearance on 2016-01-12, under 510(k) number K153012.
Who is the listed applicant for Sofia Influenza A+B FIA?
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 Sofia Influenza A+B FIA?
The FDA product code for Sofia Influenza A+B FIA is PSZ.
相关临床试验
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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：PSZ）
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。
K254262索菲亚流感A+B快速免疫分析；索菲亚呼吸道合胞病毒快速免疫分析；索菲亚链球菌A+快速免疫分析Ortho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check流感A+B测试Nano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy®流感A&B测试与Acucy® 2系统SEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd
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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