索拉那HSV 1+2/VZV檢測試劑
K 號：K162451 · 2016-11-28
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器材摘要
Solana HSV 1+2/VZV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-11-28 under 510(k) number K162451. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Solana HSV 1+2/VZV Assay?
Solana HSV 1+2/VZV Assay is a medical device that received FDA 510(k) clearance on 2016-11-28. The listed applicant is Quidel Corporation. The 510(k) number is K162451.
When did Solana HSV 1+2/VZV Assay receive FDA 510(k) clearance?
Solana HSV 1+2/VZV Assay received FDA 510(k) clearance on 2016-11-28, under 510(k) number K162451.
Who is the listed applicant for Solana HSV 1+2/VZV Assay?
The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solana HSV 1+2/VZV Assay?
The FDA product code for Solana HSV 1+2/VZV Assay is PGI.
相關臨床試驗
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其他以 Quidel Corporation 為申請人之記錄
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：PGI）
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。
K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K232286薩凡納HSV 1+2/VZV檢測，薩凡納HSV 1+2/VZV控制組，薩凡納儀器Quidel CorporationK192376Simplexa VZV Swab Direct，Simplexa VZV 阳性控制組合包Diasorin Molecular, LLCK180559HSV 1 & 2 ELITe MGB Kit；ELITe InGeniusElitechgroupK173798Simplexa HSV 1 & 2 直接檢測，Simplexa HSV 1 & 2 阳性控制組包Diasorin Molecular, LLC
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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