BinaxNOW COVID-19 Ag 卡
K号: K250273 · 2025-06-13
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决定日期2025-06-13
产品代码QVF
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器械摘要
BinaxNOW COVID-19 Ag Card is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250273. 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 BinaxNOW COVID-19 Ag Card?
BinaxNOW COVID-19 Ag Card is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K250273.
When did BinaxNOW COVID-19 Ag Card receive FDA 510(k) clearance?
BinaxNOW COVID-19 Ag Card received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250273.
Who is the listed applicant for BinaxNOW COVID-19 Ag Card?
FDA 510(k)记录将阿伯特诊断斯卡伯勒公司（Abbott Diagnostics Scarborough, Inc.）列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for BinaxNOW COVID-19 Ag Card?
The FDA product code for BinaxNOW COVID-19 Ag Card is QVF.
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。
列明Abbott Diagnostics Scarborough, Inc.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：QVF）
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。
K254264Sofia 2 SARS抗原+快速免疫分析；Sofia 2莱姆病快速免疫分析Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)K253882CorDx Tyfast COVID-19 Ag 快速检测试剂CorDx, Inc.K251289WELLlife 新冠抗原检测处方Guangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK233358SCoV-2 Ag Detect 快速检测InBios International, Inc.K232377Healgen 快速COVID-19抗原测试Healgen Scientific,, LLC
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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