2,542 results · 21ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) CDx Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

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

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY® Anti-c-KIT (9.7) Primary Antibody

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Epi proColon

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·Ventana PD-Ll (SP142) Assay

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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