K-number	K230440
Device name	Xpert® Xpress CoV-2 plus
Applicant	Cepheid®
Product code	QQX
Device class	Class II
Decision date	Oct 13, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert® Xpress CoV-2 plus

Everything you need for a 510(k) submission. Nothing you don't.