286 results · 15ms · Sources: EU EUDAMED, US FDA

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System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·AB -HAVK

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX(R) HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HERCEP TEST

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

FDA Pre-Market Approval
FDA Class 3 ·HER2 IQFISH PHARMDX

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

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

FDA Pre-Market Approval
FDA Class 3 ·HER2 FISH PHARMDX KIT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication)

System, Test, Her-2/Neu, Ihc

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC NIVOLUMAB PHARMDX