FDA 510(k)

美國疾病管制局人類流感病毒實時RT-PCR檢測組合：B屬流感病毒基因分型試劑套件

K 號：K181736 · 2018-07-30

申請人Centers For Disease Control and Prevention (CDC)

決定日期2018-07-30

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 B Lineage Genotyping Kit, is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181736. 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 B Lineage Genotyping Kit,?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K181736.

When did CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181736.

Who is the listed applicant for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) 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 B Lineage Genotyping Kit,?

The FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is OZE.

其他以 Centers For Disease Control and Prevention (CDC) 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。

K170940里氏體實時PCR檢測試劑 K161556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

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。

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