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FDA 510(k)

美國疾病管制與預防中心人類流感病毒實時RT-PCR診斷組合，流感A/B分型套件，美國疾病管制與預防中心人類流感病毒實時RT-PCR診斷組合，流感A亞型分型套件，美國疾病管制與預防中心人類流感病毒實時RT-PCR，流感B系統發育基因分型套件，美國疾病管制與預防中心人類流感病毒實時RT-PCR，流感A/HS亞型分型套件

K 號：K190302 · 2019-03-27

申請人Centers for Disease Control and Prevention
決定日期2019-03-27
產品代碼OZE
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

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K190302. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K190302.

When did CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190302.

Who is the listed applicant for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit?

The FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit is OZE.

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。

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其他以 Centers for Disease Control and Prevention 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。

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相關器械（代碼：OZE）

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。

K243274美國疾病管制局人類流感病毒實時RT-PCR檢測組合：流感A/B分型套件（版本2）；流感A亞型分型套件（版本4）；流感B基因分型套件（版本1.1和2）；以及流感A/H5亞型分型套件（版本4）Centers for Disease Control and PreventionK243931美國疾病管制局人類流感病毒實時RT-PCR檢測組合：流感A/B分型套件（版本2）；流感A亞型分型套件（版本4）；流感B系統發育基因分型套件（版本1.1和2）；以及流感A/H5亞型分型套件（版本4）Centers for Disease Control and PreventionK241110美國疾病管制局人類流感病毒實時RT-PCR檢測組合，流感A型亞型分類套件（Ver4）Centers for Disease Control and PreventionK230236麗拉A+B型流感檢測試劑Quidel CorporationK220801ID Now儀器，ID Now A型及B型流感2，ID NOW 链球菌A 2Abbott Diagnostics Scarborough, Inc.K200370美國疾病管制局人類流感病毒實時RT-PCR診斷組合，流感A/B分型套件，美國疾病管制局人類流感病毒實時RT-PCR診斷組合，流感A亞型分型套件，美國疾病管制局人類流感病毒實時RT-PCR，流感A/H5亞型分型套件Centers for Disease Control and Prevention

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