System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC NIVOLUMAB PHARMDX

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen® KRAS RGQ PCR Kit

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·Progensa PCA3 Assay

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS KRAS MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologaurd

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit