索菲亞肺炎鏈球菌A+ FIA，索菲亞2分析儀
K 號：K171976 · 2017-12-21
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器材摘要
Sofia Strep A+ FIA, Sofia 2 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171976. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sofia Strep A+ FIA, Sofia 2 Analyzer?
Sofia Strep A+ FIA, Sofia 2 Analyzer is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Quidel Corporation. The 510(k) number is K171976.
When did Sofia Strep A+ FIA, Sofia 2 Analyzer receive FDA 510(k) clearance?
Sofia Strep A+ FIA, Sofia 2 Analyzer received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171976.
Who is the listed applicant for Sofia Strep A+ FIA, Sofia 2 Analyzer?
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 Sofia Strep A+ FIA, Sofia 2 Analyzer?
The FDA product code for Sofia Strep A+ FIA, Sofia 2 Analyzer is GTY.
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：GTY）
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。
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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