GenBody COVID-19 Ag 家庭检测
K号: K251916 · 2026-03-13
广告
申请人Genbody.Inc.
决定日期2026-03-13
产品代码QYT
咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
GenBody COVID-19 Ag Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Genbody.Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251916. 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 GenBody COVID-19 Ag Home Test?
GenBody COVID-19 Ag Home Test is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Genbody.Inc.. The 510(k) number is K251916.
When did GenBody COVID-19 Ag Home Test receive FDA 510(k) clearance?
GenBody COVID-19 Ag Home Test received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251916.
Who is the listed applicant for GenBody COVID-19 Ag Home Test?
The FDA 510(k) record lists Genbody.Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GenBody COVID-19 Ag Home Test?
The FDA product code for GenBody COVID-19 Ag Home Test is QYT.
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。
相关器械（代码：QYT）
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。
K260754Fastep COVID-19 抗原笔家用检测；Fastep COVID-19 抗原笔检测Assure Tech., LLCK260095Heal-Check 快速COVID-19抗原自测Healgen Scientific,, LLCK251595COVID-19 快速自测InBios International, Inc.K251753GenaCheck COVID-19 快速自我检测Genabio Diagnostics, Inc.K241313OHC COVID-19 抗原自测Osang, LLCK243518BinaxNOW® COVID-19 抗原自测Abbott Diagnostics Scarborough, Inc.
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。
广告