Name: Predicase
Price: 199 USD

K-number	K190441
Device name	Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
Applicant	Cepheid
Product code	QEP
Device class	Class II
Decision date	May 23, 2019
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

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