K-number	DEN240016
Device name	Xpert HCV; GeneXpert Xpress System
Applicant	Cepheid
Product code	SBP
Device class	Class II
Decision date	Jun 27, 2024
Decision	Not Substantially Equivalent
Regulation	866.3171

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View the full FDA submission: accessdata.fda.gov

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Xpert HCV; GeneXpert Xpress System

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