FDA 510(k)

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

K号: K160161 · 2016-02-24

决定日期2016-02-24

产品代码PSZ

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决定实质等同

器械摘要

BD Veritor 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 Becton, Dickinson & CO. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K160161. 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 Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K160161.

When did BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit receive FDA 510(k) clearance?

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit received FDA 510(k) clearance on 2016-02-24, under 510(k) number K160161.

Who is the listed applicant for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit?

The FDA product code for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit is PSZ.

列明Becton, Dickinson & CO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。

K160164BD Veritor System for Rapid Detection of Flu A + B 实验室套装

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 Corporation K250398Innovita 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, LLC K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd

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