FDA 510(k)

里氏體實時PCR檢測試劑

K 號：K170940 · 2017-06-29

申請人Centers For Disease Control and Prevention (CDC)

決定日期2017-06-29

產品代碼PVQ

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

Rickettsia Real-time PCR Assay 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 2017-06-29 under 510(k) number K170940. The device is classified under product code PVQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rickettsia Real-time PCR Assay?

Rickettsia Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K170940.

When did Rickettsia Real-time PCR Assay receive FDA 510(k) clearance?

Rickettsia Real-time PCR Assay received FDA 510(k) clearance on 2017-06-29, under 510(k) number K170940.

Who is the listed applicant for Rickettsia Real-time PCR Assay?

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 Rickettsia Real-time PCR Assay?

The FDA product code for Rickettsia Real-time PCR Assay is PVQ.

其他以 Centers For Disease Control and Prevention (CDC) 為申請人之記錄

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K181736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 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

官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 Centers For Disease Control and Prevention (CDC) 為申請人之記錄

官方來源