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FDA 510(k)

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

K号: K223016 · 2023-01-27

申请人Bd
决定日期2023-01-27
产品代码PSZ
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决定实质等同

器械摘要

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K223016. 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 BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Bd. The 510(k) number is K223016.

When did BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit receive FDA 510(k) clearance?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K223016.

Who is the listed applicant for BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

The FDA 510(k) record lists Bd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

The FDA product code for BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is PSZ.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Bd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。

K253445BD Surgiphor™ 1000 mL 抗菌冲洗系统 (910120)K240257Denali™ 下腔静脉滤过系统 – 髂股部和颈静脉/锁骨下输送套件K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitK221504BD Surgiphor™ 抗菌冲洗系统K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

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 KitBdK192719Osom Ultra Plus 流感A&B测试套件SEKISUI Diagnostics, LLC

官方来源

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