Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

FDA classification

FDA Class 2 ·Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Tryptase Assay System

FDA classification

FDA Class 2 ·Tryptase Assay System

Computerized Cognitive Assessment Aid For Concussion

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid For Concussion

Chest X-Ray Computer Aided Detection

FDA classification

FDA Class 2 ·Chest X-Ray Computer Aided Detection

Hearing Aid, Air Conduction, Transcutaneous System

FDA classification

FDA Class 2 ·Hearing Aid, Air Conduction, Transcutaneous System

Tympanic Membrane Direct Contact Hearing Aid

FDA classification

FDA Class 2 ·Tympanic Membrane Direct Contact Hearing Aid

Hearing Aid, Group And Auditory Trainer

FDA classification

FDA Class 2 ·Hearing Aid, Group And Auditory Trainer

Cpr Aid Feedback Device (No Software)

FDA classification

FDA Class 2 ·Cpr Aid Feedback Device (No Software)

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Pediatric Autism Spectrum Disorder Diagnosis Aid

FDA classification

FDA Class 2 ·Pediatric Autism Spectrum Disorder Diagnosis Aid

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

FDA classification

FDA Class 2 ·Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Anti-Glutamate Receptor (Type Nmda) Ifa

FDA classification

FDA Class 2 ·Anti-Glutamate Receptor (Type Nmda) Ifa