Name: Predicase
Price: 199 USD

K-number	K143302
Device name	Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
Applicant	Cepheid
Product code	PEU
Device class	Class II
Decision date	Feb 12, 2015
Decision	Substantially Equivalent
Regulation	866.3373

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

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