227 results · 18ms · Sources: EU EUDAMED, US FDA

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, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·HER2FISH PHARMDX KIT

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

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

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

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

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

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

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

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

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

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

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

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