Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PREPSTAIN SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

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

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

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

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·Ventana ALK (D5F3) CDx Assay

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·MyChoice® CDx

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EGFR Mutation Test, v2.0

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology