FDA 510(k)

Sofia 2 SARS抗原+ FIA；Sofia 2 SARS抗原+ FIA控制拭子套装

K号: K233688 · 2023-12-13

决定日期2023-12-13

产品代码QVF

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决定实质等同

器械摘要

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K233688. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Quidel Corporation. The 510(k) number is K233688.

When did Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set receive FDA 510(k) clearance?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set received FDA 510(k) clearance on 2023-12-13, under 510(k) number K233688.

Who is the listed applicant for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

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 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

The FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is QVF.

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。

K231795QuickVue COVID-19 测试 K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器 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

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官方来源

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