FDA 510(k)

BioFire COVID-19 测试 2

K号: K221460 · 2022-07-25

决定日期2022-07-25

产品代码QQX

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

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 2022-07-25 under 510(k) number K221460. 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 2022-07-25. The listed applicant is Biofire Defense, LLC. The 510(k) number is K221460.

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

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2022-07-25, under 510(k) number K221460.

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 K211079BioFire COVID-19 测试 2 K202382FilmArray 全球发热面板外部控制套件

查看所有 8 个设备 →

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。