K-number	K231381
Device name	Xpert Xpress MVP; GeneXpert Xpress System
Applicant	Cepheid
Product code	PQA
Device class	Class II
Decision date	Oct 19, 2023
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 Xpress System

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