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FDA 510(k)

BioFire 全球发热面板，BioFire SHIELD 控制试剂盒用于 BioFire 全球发热面板

K号: K220870 · 2022-10-20

申请人Biofire Defense, LLC
决定日期2022-10-20
产品代码QMV
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决定实质等同

器械摘要

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever 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 2022-10-20 under 510(k) number K220870. The device is classified under product code QMV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel?

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Biofire Defense, LLC. The 510(k) number is K220870.

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

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel received FDA 510(k) clearance on 2022-10-20, under 510(k) number K220870.

Who is the listed applicant for BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever 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 Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel?

The FDA product code for BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is QMV.

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K213362BioFire 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：QMV）

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。

K243463BIOFIRE FILMARRAY 热带病检测板Biofire Diagnostics, LLC (Biomerieux)

官方来源

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