Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Hearing Aid, Master

FDA classification

FDA Class 2 ·Hearing Aid, Master

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

DermaSensor

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Computerized Cognitive Assessment Aid

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Cardiopulmonary Resuscitation Aid Kit

FDA classification

FDA Class 2 ·Cardiopulmonary Resuscitation Aid Kit

Hearing Aid, Bone Conduction

FDA classification

FDA Class 2 ·Hearing Aid, Bone Conduction

Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

Intraoperative Orthopedic Joint Assessment Aid

FDA classification

FDA Class 2 ·Intraoperative Orthopedic Joint Assessment Aid

Computerized Cognitive Assessment Aid, Exempt

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid, Exempt

Air-Conduction Hearing Aid Software

FDA classification

FDA Class 2 ·Air-Conduction Hearing Aid Software

Hearing Aid, Bone Conduction, Implanted

FDA classification

FDA Class 2 ·Hearing Aid, Bone Conduction, Implanted

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS