K-number	K222638
Device name	Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Applicant	Cepheid
Product code	NJR
Device class	Class I
Decision date	Sep 27, 2023
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

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