FDA 510(k)

BinaxNOW™ COVID-19 抗原自測包

K 號：K243518 · 2025-02-11

決定日期2025-02-11

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

BinaxNOW™ COVID-19 Antigen Self Test 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 2025-02-11 under 510(k) number K243518. 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 BinaxNOW™ COVID-19 Antigen Self Test?

BinaxNOW™ COVID-19 Antigen Self Test is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K243518.

When did BinaxNOW™ COVID-19 Antigen Self Test receive FDA 510(k) clearance?

BinaxNOW™ COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243518.

Who is the listed applicant for BinaxNOW™ COVID-19 Antigen Self Test?

FDA 510(k) 記錄將 Abbott Diagnostics Scarborough, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BinaxNOW™ COVID-19 Antigen Self Test?

The FDA product code for BinaxNOW™ COVID-19 Antigen Self Test is QYT.

其他以 Abbott Diagnostics Scarborough, Inc. 為申請人之記錄

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。

K262747ID NOW 間接流感A&B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0 K250273BinaxNOW COVID-19 抗原卡 K232775ID NOW 流感A&B 2 K221925ID NOW COVID-19 2.0 K220801ID Now儀器，ID Now A型及B型流感2，ID NOW 链球菌A 2 K191534ID NOW 流感A&B 2

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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., LLC K260095治康快速COVID-19抗原自測包Healgen Scientific,, LLC K251916GenBody COVID-19 Ag 家庭檢測Genbody.Inc.K251595COVID-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, LLC

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。