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

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Colon Computed Tomography System, Computer Aided Detection

FDA classification

FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

Instruments Designed For Press-Fit Osteochondral Implants

FDA classification

FDA Class 2 ·Instruments Designed For Press-Fit Osteochondral Implants

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification

FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Lung Computed Tomography System, Computer-Aided Detection

FDA classification

FDA Class 2 ·Lung Computed Tomography System, Computer-Aided Detection

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification

FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Anti-Phospholipase A2 Receptor

FDA classification

FDA Class 2 ·Anti-Phospholipase A2 Receptor

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Aptima CMV Quant Assay

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

FDA classification

FDA Class 2 ·Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

FDA classification

FDA Class 2 ·Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Anti-Ss-A Ro60 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A Ro60 Autoantibodies

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

FDA classification

FDA Class 2 ·Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

FDA classification

FDA Class 2 ·Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER