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FDA 510(k)

BioFire 全球发热特殊病原体面板；BioFire SHIELD 控制试剂盒用于 BioFire 全球发热特殊病原体面板

K号: K213362 · 2023-03-22

申请人Biofire Defense, LLC
决定日期2023-03-22
产品代码QVR
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决定实质等同

器械摘要

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K213362. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Biofire Defense, LLC. The 510(k) number is K213362.

When did BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel receive FDA 510(k) clearance?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel received FDA 510(k) clearance on 2023-03-22, under 510(k) number K213362.

Who is the listed applicant for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

FDA 510(k)记录显示，Biofire Defense, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

The FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is QVR.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Biofire Defense, LLC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。

K261475BIOFIRE® FILMARRAY® 热带发热检测控制试剂盒K243822BioFire 战士面板；BioFire 战士面板控制试剂盒K220870BioFire 全球发热面板，BioFire SHIELD 控制试剂盒用于 BioFire 全球发热面板K221460BioFire COVID-19 测试 2K211079BioFire COVID-19 测试 2K202382FilmArray 全球发热面板外部控制套件

查看所有 8 个设备 →

相关器械（代码：QVR）

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。

K261362Xpert 出血热检测设备CepheidK231336T2生物威胁检测板T2biosystems, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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