FDA 510(k)

ID NOW 流感A&B 2

K 號：K191534 · 2019-07-11

決定日期2019-07-11

產品代碼OCC

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 Influenza A & B 2 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 2019-07-11 under 510(k) number K191534. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K191534.

When did ID NOW Influenza A & B 2 receive FDA 510(k) clearance?

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2019-07-11, under 510(k) number K191534.

Who is the listed applicant for ID NOW Influenza A & B 2?

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 Influenza A & B 2?

The FDA product code for ID NOW Influenza A & B 2 is OCC.

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 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

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相關器械（代碼：OCC）

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 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原體面板 (RPP)Applied BioCode, Inc.K242613NxTAG® 呼吸道病原體檢測組合Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A&B 2Abbott Diagnostics Scarborough, Inc.K231017山貓融合AdV/hMPV/RV檢測試劑Hologic, Inc.K213822cobas Influenza A/B & RSV 遺伝子核酸檢測儀，適用於cobas Liat System系統Roche Molecular Systems, Inc.

官方來源

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