Name: Predicase
Price: 199 USD

K-number	K180218
Device name	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Applicant	Cepheid
Product code	OCC
Device class	Class II
Decision date	Jul 24, 2018
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

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