CorDx Tyfast COVID-19 Ag 快速检测试剂
K号: K253882 · 2026-06-01
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器械摘要
CorDx Tyfast COVID-19 Ag Rapid Test Rx is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K253882. 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 CorDx Tyfast COVID-19 Ag Rapid Test Rx?
CorDx Tyfast COVID-19 Ag Rapid Test Rx is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is CorDx, Inc.. The 510(k) number is K253882.
When did CorDx Tyfast COVID-19 Ag Rapid Test Rx receive FDA 510(k) clearance?
CorDx Tyfast COVID-19 Ag Rapid Test Rx received FDA 510(k) clearance on 2026-06-01, under 510(k) number K253882.
Who is the listed applicant for CorDx Tyfast COVID-19 Ag Rapid Test Rx?
The FDA 510(k) record lists CorDx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx?
The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx is QVF.
相关临床试验
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列明CorDx, 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)K251289WELLlife 新冠抗原检测处方Guangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag 卡Abbott Diagnostics Scarborough, Inc.K233358SCoV-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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