K-number	K231481
Device name	Xpert Xpress CoV-2/Flu/RSV plus
Applicant	Cepheid®
Product code	QOF
Device class	Class II
Decision date	Aug 17, 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/Flu/RSV plus

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