FDA 510(k)

The Sensititre YeastOne 敏感性系统，含有雷扎芬净，稀释范围为0.008-8ug/mL

K号: K231433 · 2023-08-31

决定日期2023-08-31

产品代码NGZ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Thermo Fisher Scientific为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252062Sensititre 18-24小时MIC或断裂点敏感性系统，含多粘菌素，稀释范围为0.12-16 μg/mL。K250575Sensititre 18-24小时MIC或断裂点敏感性系统，含阿奇霉素/阿维巴坦，稀释范围为0.008/4 - 64/4 μg/mL。K252014Sensititre 18-24小时MIC或断裂点敏感性系统，含阿米卡星，稀释范围为0.25-256 μg/mL。K250990Sensititre 18-24小时MIC或断裂点敏感性系统，含环丙沙星，稀释范围为0.002-64 μg/mL。K242843Sensititre 20-24小时流感嗜血杆菌/肺炎链球菌（HP）MIC或断裂点敏感性系统，含头孢匹罗，稀释范围为0.008-16 μg/mL。K242659Sensititre 18-24小时MIC或断裂点敏感性系统，含万古霉素，稀释范围为0.25-128 μg/mL。

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相关器械（代码：NGZ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243738The Sensititre YeastOne 敏感性系统，含有米卡芬净，稀释范围为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-酵母阿尼鲁兰（<= 0.015 - >= 8 µg/mL）bioMerieux, Inc.K221198Sensititre YeastOne敏感性系统，含Fluconazole，稀释范围为0.12-128ug/mLThermo Fisher Scientific K221899The Sensititre YeastOne 敏感性系统，含有卡泊芬净，稀释范围为0.015-16ug/mlThermo Fisher Scientific K211539Sensititre YeastOne敏感性系统，含Voriconazole，稀释范围为0.008 - 8 ug/mLThermo Fisher Scientific

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