NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

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

The Multimodality Advanced Vessel Analysis

FDA 510(k)

FDA Class 2 ·Radiology

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

B.R.A.H.M.S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Lung Nodule Assessment and Comparison Option (LNA)

FDA 510(k)

FDA Class 2 ·Radiology

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

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular