Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR

Advanced Diffusion Analysis (ADA) application

FDA 510(k)

FDA Class 2 ·Radiology

Longitudinal Brain Imaging (LoBI) application

FDA 510(k)

FDA Class 2 ·Radiology

ALLURA XPER FD10

FDA 510(k)

FDA Class 2 ·Radiology

Multi-Modality Tumor Tracking (MMTT) application

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV/COBAS AMPLICOR HCV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV, and Atellica HCV

The Multimodality Advanced Vessel Analysis

FDA 510(k)

FDA Class 2 ·Radiology

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV, Alinity i Anti-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV / Alinity i Anti-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

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

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV and Alinity i Anti-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Architect Anti-HCV and Alinity i Anti-HCV