Name: Predicase
Price: 199 USD

K-number	K142501
Device name	Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Applicant	Cepheid
Product code	PCH
Device class	Class II
Decision date	Nov 26, 2014
Decision	Substantially Equivalent
Regulation	866.3990

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View the full FDA submission: accessdata.fda.gov

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Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

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