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FDA 510(k)

GenBody COVID-19 Ag 家庭檢測

K 號：K251916 · 2026-03-13

申請人Genbody.Inc.
決定日期2026-03-13
產品代碼QYT
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QYT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260754Fastep COVID-19 抗原筆式家庭檢測；Fastep COVID-19 抗原筆式檢測Assure Tech., LLCK260095治康快速COVID-19抗原自測包Healgen Scientific,, LLCK251595COVID-19 快速自測檢測器InBios International, Inc.K251753GenaCheck COVID-19 快速自測包Genabio Diagnostics, Inc.K241313OHC COVID-19 抗原自測包Osang, LLCK243518BinaxNOW™ COVID-19 抗原自測包Abbott Diagnostics Scarborough, Inc.

官方來源

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