Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer

Product	Model	Company	Device type
Birlinn BCR-ABL1 p210 IS Panel C230MmqciPhiladelphia chromosome/BCR-ABL transcript IVD, control	v.00	Mmqci	Philadelphia chromosome/BCR-ABL transcript IVD, control
cobas® EGFR Mutation Test v2Roche Molecular Systems, Inc.Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	2.0	Roche Molecular Systems, Inc.	Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Eonis SCID-SMA kitWallac OyMultiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)	3241-001U	Wallac Oy	Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)
Eonis SCID-SMA kitWallac OyMultiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)	3242-001U	Wallac Oy	Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)
Idylla CDx MSI TestBiocartis NVMicrosatellite instability IVD, kit, nucleic acid technique (NAT)	v3	Biocartis NV	Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Idylla™ MSI FFPE Reference SetSensID GmbHExogenous DNA/RNA internal control IVD, kit	2x5	SensID GmbH	Exogenous DNA/RNA internal control IVD, kit
Idylla™ MSI TestBiocartis NVMicrosatellite instability IVD, kit, nucleic acid technique (NAT)	2	Biocartis NV	Microsatellite instability IVD, kit, nucleic acid technique (NAT)
ipsogen® JAK2 RGQ PCR KitQIAGEN GmbHJAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)	V1	QIAGEN GmbH	JAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)
Local Run Manager CF 139 Variant Analysis ModuleIllumina, Inc.Cystic fibrosis IVD, kit, multiplex	20047009	Illumina, Inc.	Cystic fibrosis IVD, kit, multiplex
Local Run Manager CF 139-Variant 2.0 Micro Analysis ModuleIllumina, Inc.Cystic fibrosis IVD, kit, multiplex	20072975	Illumina, Inc.	Cystic fibrosis IVD, kit, multiplex
Local Run Manager CF Clinical Sequencing Analysis ModuleIllumina, Inc.Cystic fibrosis IVD, kit, multiplex	20046734	Illumina, Inc.	Cystic fibrosis IVD, kit, multiplex
MammaPrint FFPEAgendia, Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	MammaPrint FFPE Microarray	Agendia, Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
OncoMate MSI Dx Analysis SystemPromega CorporationMicrosatellite instability IVD, kit, nucleic acid technique (NAT)	MD2140	Promega Corporation	Microsatellite instability IVD, kit, nucleic acid technique (NAT)
OncoMate® MSI Dx Assay InstallerPromega CorporationMicrosatellite instability IVD, kit, nucleic acid technique (NAT)	MD4130	Promega Corporation	Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Oncomine™ Dx Target TestLife Technologies CorporationMultiple tissue-associated protein/tumour marker IVD, reagent	A32441	Life Technologies Corporation	Multiple tissue-associated protein/tumour marker IVD, reagent
oncoReveal CDx Box 3Pillar Biosciences, Inc.Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)	HDA-LC-2001-48-3	Pillar Biosciences, Inc.	Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
PGDx elio™ serverPersonal Genome Diagnostics Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	B-01-20800	Personal Genome Diagnostics Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
PGDx elio™ serverPersonal Genome Diagnostics Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	B-01-40800	Personal Genome Diagnostics Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	PROSIGNA-002	Nanostring Technologies, Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	PROSIGNA-003	Nanostring Technologies, Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc.Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	PROSIGNA-010	Nanostring Technologies, Inc.	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
SensID Idylla™ MSI FFPE Reference SetSensID GmbHExogenous DNA/RNA internal control IVD, kit	2x2	SensID GmbH	Exogenous DNA/RNA internal control IVD, kit
TruSight™ Oncology DNA Control v2Illumina, Inc.Cancer-related multiple gene mutation profile IVD, control	20090155	Illumina, Inc.	Cancer-related multiple gene mutation profile IVD, control
TruSight™ Oncology RNA ControlIllumina, Inc.Cancer-related multiple gene mutation profile IVD, control	20065042	Illumina, Inc.	Cancer-related multiple gene mutation profile IVD, control
Xpert BCR-ABL IS Panel C130MmqciPhiladelphia chromosome/BCR-ABL transcript IVD, control	v.00	Mmqci	Philadelphia chromosome/BCR-ABL transcript IVD, control