試劑，基因分類，乙型肝炎C病毒
PMA 核准號：P160016 · 2020-09-23
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決定日期2020-09-23
PMA 編號P160016
產品代碼OBF
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
Assay, genotyping, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Europe N.V.. It received FDA 510(k) clearance on 2020-09-23. The device is classified under product code OBF. It was reviewed by the MI advisory panel.
常見問題
What is the Assay, genotyping, hepatitis c virus?
Assay, genotyping, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Fujirebio Europe N.V..
When did Assay, genotyping, hepatitis c virus receive FDA 510(k) clearance?
The clearance date for Assay, genotyping, hepatitis c virus can be found in the official FDA records.
Who is the listed applicant for Assay, genotyping, hepatitis c virus?
The FDA 510(k) record lists Fujirebio Europe N.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assay, genotyping, hepatitis c virus?
The FDA product code for Assay, genotyping, hepatitis c virus is OBF.
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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