FDA 510(k)

BioFire COVID-19 测试 2

K号: K211079 · 2021-11-01

决定日期2021-11-01

产品代码QQX

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决定实质等同

器械摘要

BioFire COVID-19 Test 2 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 2021-11-01 under 510(k) number K211079. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioFire COVID-19 Test 2?

BioFire COVID-19 Test 2 is a medical device that received FDA 510(k) clearance on 2021-11-01. The listed applicant is Biofire Defense, LLC. The 510(k) number is K211079.

When did BioFire COVID-19 Test 2 receive FDA 510(k) clearance?

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2021-11-01, under 510(k) number K211079.

Who is the listed applicant for BioFire COVID-19 Test 2?

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 COVID-19 Test 2?

The FDA product code for BioFire COVID-19 Test 2 is QQX.

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 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 2 K202382FilmArray 全球发热面板外部控制套件

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