FDA 510(k)

非天花正痘病毒實時PCR引物及探針組

K 號：K221834 · 2022-06-24

申請人Centers for Disease Control and Prevention

決定日期2022-06-24

產品代碼PBK

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

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set 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 2022-06-24 under 510(k) number K221834. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K221834.

When did Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set receive FDA 510(k) clearance?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set received FDA 510(k) clearance on 2022-06-24, under 510(k) number K221834.

Who is the listed applicant for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

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 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is PBK.

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。

K260812弗朗西斯菌屬實時PCR檢測試劑 K252072弗朗西斯菌屬實時PCR檢測試劑 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）K243931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）K241110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）K222558非天花正痘病毒實時PCR引物及探針組

查看所有 13 項裝置 →

相關器械（代碼：PBK）

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。

K222558非天花正痘病毒實時PCR引物及探針組Centers for Disease Control and Prevention K221658非天花正痘病毒實時PCR引物及探針組Centers for Disease Control and Prevention K181205非天花正痘病毒實時PCR引物及探針組Centers for Disease Control and Prevention

官方來源

在 FDA 資料庫中查看 →

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。