Xpert® Xpress CoV-2 plus
K-Number: K230440 · 2023-10-13
ApplicantCepheid®
Decision Date2023-10-13
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert® Xpress CoV-2 plus is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2023-10-13 under approval number K230440. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert® Xpress CoV-2 plus?
Xpert® Xpress CoV-2 plus is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Cepheid®. The 510(k) number is K230440.
When was Xpert® Xpress CoV-2 plus approved by the FDA?
Xpert® Xpress CoV-2 plus received FDA 510(k) clearance on 2023-10-13, under approval number K230440.
What company makes Xpert® Xpress CoV-2 plus?
Xpert® Xpress CoV-2 plus is manufactured by Cepheid®.
What is the FDA product code for Xpert® Xpress CoV-2 plus?
The FDA product code for Xpert® Xpress CoV-2 plus is QQX.
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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.