AMEBIASIS MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

E. HISTOLYTICA QUIK CHEK

FDA 510(k)

FDA Class 2 ·Microbiology

ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)

FDA 510(k)

FDA Class 2 ·Microbiology

HILLCREST AMEBIASIS IHA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GIARDIA STOOL ANTIGEN TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)

FDA 510(k)

FDA Class 2 ·Microbiology

AMEBIASIS ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

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