巨细胞病毒（CMV）DNA定量試驗
PMA 核准號：P130027 · 2018-09-26
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申請人Qiagen, Inc.
決定日期2018-09-26
PMA 編號P130027
產品代碼PAB
器械分類2 類
醫療專科M
法規編號21 CFR 8
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
器材摘要
Cytomegalovirus (cmv) dna quantitative assay is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2018-09-26. The device is classified under product code PAB. It was reviewed by the MI advisory panel.
常見問題
What is the Cytomegalovirus (cmv) dna quantitative assay?
Cytomegalovirus (cmv) dna quantitative assay is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Qiagen, Inc..
When did Cytomegalovirus (cmv) dna quantitative assay receive FDA 510(k) clearance?
The clearance date for Cytomegalovirus (cmv) dna quantitative assay can be found in the official FDA records.
Who is the listed applicant for Cytomegalovirus (cmv) dna quantitative assay?
The FDA 510(k) record lists Qiagen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cytomegalovirus (cmv) dna quantitative assay?
The FDA product code for Cytomegalovirus (cmv) dna quantitative assay is PAB.
相關臨床試驗
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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。
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