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

Respiratory Virus Panel Nucleic Acid Assay System

Cepheid

The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Flu/rsv, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, Genexpert Xpress Ii, Genexpert Xpress Iv.

Pre-market Notification Details

Device IDK180218
510k NumberK180218
Device Name:Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant Cepheid 904 Caribbean Drive Sunnyvale,  CA  94089
ContactYi-ping Lin
CorrespondentJim Kelly
Cepheid 904 Caribbean Drive Sunnyvale,  CA  94089
Product CodeOCC  
Subsequent Product CodeJSM
Subsequent Product CodeOOI
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-25
Decision Date2018-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332940007195 K180218 000

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