Xpert Xpress CoV-2/Flu/RSV plus
K-Number: K250996 · 2025-05-01
ApplicantCepheid®
Decision Date2025-05-01
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert Xpress CoV-2/Flu/RSV plus is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2025-05-01 under approval number K250996. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert Xpress CoV-2/Flu/RSV plus?
Xpert Xpress CoV-2/Flu/RSV plus is a medical device that received FDA 510(k) clearance on 2025-05-01. It is manufactured by Cepheid®. The 510(k) number is K250996.
When was Xpert Xpress CoV-2/Flu/RSV plus approved by the FDA?
Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance on 2025-05-01, under approval number K250996.
What company makes Xpert Xpress CoV-2/Flu/RSV plus?
Xpert Xpress CoV-2/Flu/RSV plus is manufactured by Cepheid®.
What is the FDA product code for Xpert Xpress CoV-2/Flu/RSV plus?
The FDA product code for Xpert Xpress CoV-2/Flu/RSV plus is QOF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.