Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DiaSorin ETI-EBK PLUS assay

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

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

FDA Pre-Market Approval

FDA Class 3 ·THE PATH VYSION HER-2 DNA PRODE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit