K-number	K221160
Device name	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Applicant	Cepheid
Product code	PQA
Device class	Class II
Decision date	Jun 7, 2022
Decision	Substantially Equivalent
Regulation	866.3975

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

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