FDA.reportPublic FDA data

Cystic fibrosis IVD, kit, multiplex

Definition
A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method.
GUDID devices
16
Last updated
2023-07-13 06:46:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816270020262Local Run Manager CF Clinical Sequencing Analysis ModuleILLUMINA, INC.200467342023-06-15
00816270020286Local Run Manager CF 139 Variant Analysis ModuleILLUMINA, INC.200470092023-06-15
00816270020378Local Run Manager CF 139-Variant 2.0 Micro Analysis ModuleILLUMINA, INC.200729752023-06-15
00816270020385Local Run Manager CF Clinical Seq 2.0 Micro Analysis ModuleILLUMINA, INC.200729742023-06-15
00840487100455xTAG® Cystic Fibrosis Mutation Detection KitLuminex Molecular Diagnostics, IncI006C00682016-09-09
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2Luminex Molecular Diagnostics, IncI024C01812016-09-09
00816270020149TruSight™ Cystic Fibrosis Library PreparationILLUMINA, INC.200369252020-04-09
00840487100141xTAG® Cystic Fibrosis (CFTR) 39 kit v2Luminex Molecular Diagnostics, IncI027C02312016-09-09
00857167005146eSensor® XT-8GENMARK DIAGNOSTICS, INC.eSensor® Cystic Fibrosis (CF)2016-09-24
00857167005153eSensor® XT-8GENMARK DIAGNOSTICS, INC.eSensor® Cystic Fibrosis (CF)2016-09-24
00857167005160eSensor® XT-8GENMARK DIAGNOSTICS, INC.eSensor® Cystic Fibrosis (CF) 2016-09-24
00857167005177eSensor® XT-8GENMARK DIAGNOSTICS, INC.eSensor® Cystic Fibrosis (CF)2016-09-24
00857167005184eSensor® XT-8GENMARK DIAGNOSTICS, INC.eSensor® Cystic Fibrosis (CF)2016-09-24
00816270020019MiSeqDx CF 139 Variant Assay (2 Run)ILLUMINA, INC.150365802016-09-21
00816270020026MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)ILLUMINA, INC.150366202016-09-21
00816270020033MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)ILLUMINA, INC.150365772017-08-14