Xpert Respiratory Panel
K号: K261336 · 2026-09-25
广告
器械摘要
Xpert Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261336. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Xpert Respiratory Panel?
Xpert Respiratory Panel is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Cepheid. The 510(k) number is K261336.
When did Xpert Respiratory Panel receive FDA 510(k) clearance?
Xpert Respiratory Panel received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261336.
Who is the listed applicant for Xpert Respiratory Panel?
The FDA 510(k) record lists Cepheid as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xpert Respiratory Panel?
The FDA product code for Xpert Respiratory Panel is QOF.
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。
列明Cepheid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。
相关器械（代码：QOF）
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。
K263054BIOFIRE Respiratory Panel 2.1 (RP2.1)Biofire DiagnosticsK261837FINDER流感A&B/SARS-CoV-2测试Baebies, Inc.K252932Fast PCR Mini 呼吸检测板Autonomous Medical Devices IncorporatedK252269FINDER流感A&B/SARS-CoV-2测试Baebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES 流感A/B，RSV & COVID-19Diasorin Molecular, LLC
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。
广告