FDA 510(k)

ID NOW COVID-19 2.0

K 號：K221925 · 2023-08-10

決定日期2023-08-10

產品代碼QWR

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

ID NOW COVID-19 2.0 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 2023-08-10 under 510(k) number K221925. The device is classified under product code QWR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ID NOW COVID-19 2.0?

ID NOW COVID-19 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K221925.

When did ID NOW COVID-19 2.0 receive FDA 510(k) clearance?

ID NOW COVID-19 2.0 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K221925.

Who is the listed applicant for ID NOW COVID-19 2.0?

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 ID NOW COVID-19 2.0?

The FDA product code for ID NOW COVID-19 2.0 is QWR.

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 K243518BinaxNOW™ COVID-19 抗原自測包 K232775ID NOW 流感A&B 2 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：QWR）

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。

K243346cobas liat SARS-CoV-2 v2 遺伝子檢測Roche Molecular Systems, Inc.K223783cobas SARS-CoV-2 遺傳子測試，適用於cobas Liat 系統Roche Molecular Systems, Inc.

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。