742 results · 108ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH2

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Alinity m HCV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

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, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval
FDA Class 3 ·VYSIS CLL FISH PROBE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REAL TIME HBV

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

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime HBV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime HBV Assay

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV