XTAG Cystic Fibrosis 39 Kit V2

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Luminex Molecular Diagnostics, Inc.

The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cystic Fibrosis 39 Kit V2.

Pre-market Notification Details

Device IDK163347
510k NumberK163347
Device Name:XTAG Cystic Fibrosis 39 Kit V2
ClassificationSystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant Luminex Molecular Diagnostics, Inc. 439 University Ave Toronto,  CA M5g1y8
ContactTina Ip
CorrespondentTina Ip
Luminex Molecular Diagnostics, Inc. 439 University Ave Toronto,  CA M5g1y8
Product CodeNUA  
CFR Regulation Number866.5900 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-28
Decision Date2016-12-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.