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FDA 510(k)

cobas Influenza A/B & RSV 鈾酸測試，適用於cobas Liat 系統

K 號：K153544 · 2016-07-25

申請人Iquum, Inc.
決定日期2016-07-25
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

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is the device name listed in this FDA 510(k) record. The listed applicant is Iquum, Inc.. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K153544. 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 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Iquum, Inc.. The 510(k) number is K153544.

When did cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System receive FDA 510(k) clearance?

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System received FDA 510(k) clearance on 2016-07-25, under 510(k) number K153544.

Who is the listed applicant for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

The FDA 510(k) record lists Iquum, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

The FDA product code for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is OCC.

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：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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