Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard Stool DNA-Based Colorectal Cancer Screening Test

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PAPNET (R) TESTING SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP-5000

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·Progensa PCA3 Assay

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·Progensa PCA3 Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·LEICA BOND ORACLE HER2 IHC SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx, F1CDx

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN KRAS RGQ PCR KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDx BRCA HRD