FDA 510(k)

QuickVue COVID-19 测试

K号: K231795 · 2024-03-22

决定日期2024-03-22

产品代码QYT

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器械摘要

QuickVue COVID-19 Test is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231795. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QuickVue COVID-19 Test?

QuickVue COVID-19 Test is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Quidel Corporation. The 510(k) number is K231795.

When did QuickVue COVID-19 Test receive FDA 510(k) clearance?

QuickVue COVID-19 Test received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231795.

Who is the listed applicant for QuickVue COVID-19 Test?

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 QuickVue COVID-19 Test?

The FDA product code for QuickVue COVID-19 Test is QYT.

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。

K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器 K233688Sofia 2 SARS抗原+ FIA；Sofia 2 SARS抗原+ FIA控制拭子套装 K230349Lyra RSV+hMPV 检测 K230236Lyra A+B 流感病毒检测 K211342Sofia 2 营养性弧菌FIA K173496Sofia 2 疥病FIA，Sofia疥病控制套装

查看所有 22 个设备 →

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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。