FDA 510(k)

Sensititre YeastOne 抗藥性測試系統，使用Rezafungin於0.008-8ug/mL的稀釋範圍內

K 號：K231433 · 2023-08-31

決定日期2023-08-31

產品代碼NGZ

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231433. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K231433.

When did The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL receive FDA 510(k) clearance?

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231433.

Who is the listed applicant for The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The FDA product code for The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is NGZ.

其他以 Thermo Fisher Scientific 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。

K252062The Sensititre 18-24 小時 MIC 或斷點敏感度系統，含聚糖素於 0.12-16 µg/mL 稀釋範圍內 K250575Sensititre 18-24小時MIC或斷點敏感度系統，含阿茲特羅胺/阿維巴坦，濃度範圍為0.008/4 - 64/4 µg/mL K252014Sensititre 18-24小時MIC或斷點敏感度系統，含阿米卡星，濃度範圍為0.25-256 µg/mL K250990Sensititre 18-24小時MIC或斷點敏感度系統，含Ciprofloxacin於0.002-64 µg/mL的稀釋範圍內 K242843Sensititre 20-24小時流感嗜血桿菌/肺炎鏈球菌（HP）MIC或斷點敏感度系統，含Ceftobiprole於0.008-16 µg/mL濃度範圍內。K242659Sensititre 18-24小時MIC或斷點敏感度系統，含去甲氧西林，濃度範圍為0.25-128 µg/mL

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相關器械（代碼：NGZ）

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。

K243738Sensititre YeastOne 抗藥性系統，含米卡芬净，濃度範圍為0.008-16 µg/mLThermo Fisher Scientific K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）bioMerieux, Inc.K232963VITEK 2 AST-酵母阿尼霉素（<= 0.015 - >= 8 µg/mL）bioMerieux, Inc.K221198Sensititre YeastOne 抗藥性測試系統，含氟康唑，濃度範圍為0.12-128ug/mLThermo Fisher Scientific K221899Sensititre YeastOne 抗藥性系統，含Caspofungin於0.015-16ug/ml濃度範圍內Thermo Fisher Scientific K211539Sensititre YeastOne 抗藥性測試系統，含伏立康唑，濃度範圍為 0.008 - 8 微克/毫升Thermo Fisher Scientific

官方來源

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