套件,人類乳突病毒,RNA偵測
PMA 核准號:P100042 · 2026-02-03
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決定日期2026-02-03
PMA 編號P100042
產品代碼OYB
器械分類3 類
醫療專科U
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
Kit, rna detection, human papillomavirus is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Incorporated. It received FDA 510(k) clearance on 2026-02-03. The device is classified under product code OYB. It was reviewed by the MI advisory panel.
常見問題
What is the Kit, rna detection, human papillomavirus?
Kit, rna detection, human papillomavirus is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Gen-Probe Incorporated.
When did Kit, rna detection, human papillomavirus receive FDA 510(k) clearance?
The clearance date for Kit, rna detection, human papillomavirus can be found in the official FDA records.
Who is the listed applicant for Kit, rna detection, human papillomavirus?
The FDA 510(k) record lists Gen-Probe Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kit, rna detection, human papillomavirus?
The FDA product code for Kit, rna detection, human papillomavirus is OYB.
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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