簡易快篩COVID-19直測
K 號：K212147 · 2022-09-13
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器材摘要
Simplexa COVID-19 Direct is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K212147. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Simplexa COVID-19 Direct?
Simplexa COVID-19 Direct is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K212147.
When did Simplexa COVID-19 Direct receive FDA 510(k) clearance?
Simplexa COVID-19 Direct received FDA 510(k) clearance on 2022-09-13, under 510(k) number K212147.
Who is the listed applicant for Simplexa COVID-19 Direct?
The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Simplexa COVID-19 Direct?
The FDA product code for Simplexa COVID-19 Direct is QQX.
相關臨床試驗
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其他以 Diasorin Molecular, LLC 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。
K260333聯繫 NES 集團 A 醜群；聯繫 NES 集團 A 醜群控制拭子套件K251978聯盟 NES 流感 A/B、RSV 及 COVID-19K252387Simplexa™ COVID-19/流感A/B & RSV直接檢測儀（MOL4450）；Simplexa™ COVID-19/流感A/B & RSV陽性控制組裝（MOL4460）K220963簡易快篩COVID-19及流感A/B直測K202755Simplexa先天性CMV直接檢測和Simplexa先天性CMV陽性控制組合包K201505Simplexa 流感A/B & RSV直接二代，Simplexa 流感A/B & RSV陽性控制組合包
相關器械（代碼：QQX）
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。
K243396Aptima SARS-CoV-2 檢測試劑Hologic, Inc.K240867cobas® SARS-CoV-2 定性檢測用於 cobas® 5800/6800/8800 系統Roche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott MolecularK233453Applied Biosystems™ TaqPath™ COVID-19 诊断PCR試劑套件Life Technologies CorporationK230440Xpert® Xpress CoV-2 plusCepheid®
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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