山貓融合GBS試劑
K 號：K181156 · 2018-07-27
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器材摘要
Panther Fusion GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diagenode. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181156. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Panther Fusion GBS Assay?
Panther Fusion GBS Assay is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Diagenode. The 510(k) number is K181156.
When did Panther Fusion GBS Assay receive FDA 510(k) clearance?
Panther Fusion GBS Assay received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181156.
Who is the listed applicant for Panther Fusion GBS Assay?
The FDA 510(k) record lists Diagenode as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Panther Fusion GBS Assay?
The FDA product code for Panther Fusion GBS Assay is NJR.
相關臨床試驗
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。
相關器械（代碼：NJR）
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。
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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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